Biosimilar pharmaceuticals. Medical search. FAQ

On 13 December 2017, Pfizer announced that the FDA had granted approval for Ixifi (Remicade biosimilar) for the treatment of multiple chronic inflammatory diseases such as ulcerative colitis (UC). (pharmaceutical-technology.com)
The Global Biosimilars market is expected grow at 23 % CAGR over 2017-2023, from USD 4.10 Billion in 2017 to USD 14.23 billion by 2023. (coalesceresearchgroup.com)
bigmarketresearch.com include new market research report "United States Biologics And Biosimilars Market Report 2017" to its huge collection of research reports. (webnewswire.com)
The global Biosimilars Market was valued at USD 3.23 billion in 2016 and is projected to reach USD 26.40 billion by 2025, growing at a CAGR of 26.29% from 2017 to 2025. (bccresearch.com)
The insight article by Alan Cassels 'Why biosimilars should be interchangeable with biologics' ( Clinical Pharmacist 2017;9:2 ) provides a great opportunity to clarify some key points. (pharmaceutical-journal.com)
On the basis of an analysis of 2017 formularies, Bernstein analyst Ronny Gal said that "nearly half the market blocked or step-edited biosimilars. (forbes.com)
The Food and Drug Administration (FDA) and European Commission approved their first biosimilar mAbs in 2016 and 2013, respectively, and have approved a total of three and six biosimilars, respectively, as of May 2017. (parexel.com)
Global Biosimilar Market is expected to grow significantly from USD 3,748 million in 2017 to USD 34,865 million in 2024, at a lucrative CAGR of 32.6% from 2018 to 2024. (pharmiweb.com)
Albany, NY -- ( SBWIRE ) -- 10/11/2017 -- This comprehensive report on the Global Biosimilars Treatment Market provides a detailed and professional assessment of the dynamics of the demand, supply, and sales of Enterprise Search and have been compiled by market experts. (sbwire.com)
The most recent short interest data has been released for the 10/31/2017 settlement date, which shows a 699,664 share increase in total short interest for Momenta Pharmaceuticals Inc , to 7,483,025, an increase of 10.31% since 10/13/2017. (thestreet.com)
In the recent times, the global market for Asia pacific biosimilars of monoclonal antibody market report 2017 has surfaced as one of the most promising markets in the pharmaceutical industry, thanks to the significant rise in research and development activities by leading vendors of Asia pacific biosimilars of monoclonal antibody market report 2017 across the world. (qyresearchreports.com)
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The research report on the Asia pacific biosimilars of monoclonal antibody market report 2017 is an analytical study which comprehensively analyzes the competitive framework of this market. (qyresearchreports.com)
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Holzkirchen, September 12, 2017 - Sandoz, a Novartis Division, and the pioneer and global leader in biosimilars, announced today that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) under the 351 (k) pathway for a proposed biosimilar to the reference medicine, Rituxan®** (rituximab). (pharmiweb.com)
We plan to launch a total of five major oncology and immunology biosimilars between 2017 and 2020. (pharmiweb.com)

FDA sponsored the session to further advance its proposed Biosimilar Action Plan and expects to receive more extensive formal comments from stakeholders by September 21, 2018. (pharmexec.com)
Basel, January 9, 2018 - Novartis announced today the initiation of SURPASS, a head-to-head clinical trial of Cosentyx ® (secukinumab) versus proposed biosimilar adalimumab** in ankylosing spondylitis (AS). (novartis.com)
Holzkirchen, Germany, October 31, 2018 - Sandoz, a Novartis division and the pioneer and global leader in biosimilars, today announced that the US Food and Drug Administration (FDA) approved its biosimilar, Hyrimoz TM (adalimumab-adaz). (novartis.com)
On October 11, 2018, Sandoz announced a global resolution of all intellectual property-related litigation with AbbVie concerning all indications of the proposed Sandoz biosimilar adalimumab for the reference medicine. (novartis.com)
instead they've settled on one, an adalimumab biosimilar, and are aiming for launch in Europe in 2018, according to recent Momenta filings. (xconomy.com)
In 2018, the U.S. spent $126 billion on biologics, less than 2% of which was on biosimilars , according to IQVIA. (forbes.com)
The Global Biosimilar Market studies the overall dynamics and trends of the market in terms of various segments and regional outlook for the period of 2018 to 2024. (pharmiweb.com)
What is the market size in 2018 and the growth rate of the Global Biosimilar Market? (pharmiweb.com)
The Biosimilar Monoclonal Antibodies Market 2018 inspects the execution of the Biosimilar Monoclonal Antibodies advertise, encasing a top to bottom judgment of the Biosimilar Monoclonal Antibodies showcase state and the aggressive scene comprehensively. (webnewswire.com)
The Global Biosimilar Monoclonal Antibodies Market 2018 report incorporates Biosimilar Monoclonal Antibodies industry volume, piece of the overall industry, showcase Trends, Biosimilar Monoclonal Antibodies Growth angles, an extensive variety of uses, Utilization proportion, Supply and request investigation, fabricating limit, Biosimilar Monoclonal Antibodies Price amid the Forecast time frame from 2018 to 2023. (webnewswire.com)
Due to the difficulty of conforming to the FDA's guidance, no biosimilar has yet been designated interchangeable as of April 2018. (drugdevelopment-technology.com)
Valley Cottage, NY -- ( SBWIRE ) -- 10/02/2018 -- Biosimilar can be defined as a type of biological product that is highly similar to an already FDA approved drug, known as reference biological product. (sbwire.com)
Investors in Momenta Pharmaceuticals Inc saw new options begin trading this week, for the January 2018 expiration. (thestreet.com)
The São Paulo State Court of Appeals established on August 27 2018 that suppliers of active pharmaceutical ingredients (APIs) for compounding pharmacies are liable for patent infringement when selling wholesale for compounding pharmacies. (managingip.com)

Researchers analysed data from 19 studies looking at the efficacy of seven biosimilars for etanercept, infliximab and adalimumab. (pharmaceutical-journal.com)
The paper, which is published in the Annals of Internal Medicine (online, 2 August 2016), looked at 19 studies involving seven biosimilars for etanercept, infliximab and adalimumab. (pharmaceutical-journal.com)
Experimental: GP2017 (adalimumab biosimilar) 40mg s.c. (clinicaltrials.gov)
To demonstrate the proportion of subjects on secukinumab (combined 150 mg s.c. and 300 mg s.c.) with no radiographic progression as measured by mSASSS at Week 104 is superior to subjects on GP2017 (adalimumab biosimilar 40 mg s.c. (clinicaltrials.gov)
BANNOCKBURN, Ill. and CAMBRIDGE, Mass., Oct. 05, 2015 (GLOBE NEWSWIRE) -- Baxalta Incorporated (NYSE:BXLT) and Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), today announced the initiation of a pivotal clinical trial in patients with chronic plaque psoriasis for M923, a biosimilar version of HUMIRA ® (adalimumab). (cnbc.com)
We look forward to bringing a high-quality and cost-effective biosimilar version of adalimumab to patients around the world. (cnbc.com)
The license enables patient access in the US to Hyrimoz (or Sandoz adalimumab or Sandoz biosimilar) as of September 30, 2023. (novartis.com)
Sandoz currently has three proposed biosimilars under review by the EMA: pegfilgrastim, adalimumab and infliximab. (pharmaceuticaldaily.com)
In the European Union (EU), the USA, Japan and other countries, biosimilars of adalimumab, etanercept, infliximab and rituximab have been approved, and those for which the bio-originator no longer is protected by patent have been marketed. (bmj.com)

The Biologics and Biosimilars World Markets ( http://www.rnrmarketresearch.com/biologics-and-biosimilars-world-markets-market-report.html ) report describes the emergence of biologics and biosimilars and their potential role in shaping the future of the global healthcare industry. (bio-medicine.org)
Moreover, this report examines companies that are actively developing and marketing biologics and biosimilars in the world. (bio-medicine.org)
Yet biologics and biosimilars are expected to run on parallel sales trajectories. (mmm-online.com)
It is important for patients to have access to safe, effective and affordable biological products and we are committed to facilitating the development and approval of biosimilar and interchangeable products," said Dr Leah Christl , Director of the Therapeutic Biologics and Biosimilars Staff in the FDA's Center for Drug Evaluation and Research. (europeanpharmaceuticalreview.com)
In May of this year, the Food and Drug Administration (FDA) released final guidance on therapeutic interchangeability between originator biologics and biosimilars. (forbes.com)

Companies like Coherus, Teva and Sandoz are expected to show a great deal of growth over the next decade as they bring more biosimilar products to market. (thebalance.com)
Teva, the world's largest maker of generic drugs, already markets biosimilars in Europe, along with generic manufacturers Sandoz and Dr. Reddy's, and pharmaceutical companies Merck & Co., Eli Lilly & Co. and AstraZeneca have recently announced the creation of biosimilars divisions.Financial terms of the deal between Lonza and Teva were not disclosed. (drugstorenews.com)
Amgen, Hospira and Sandoz Named Among Top Pharmaceutical Companies with Greatest Biosimilar Drug Potential in Uni. (bio-medicine.org)
It also identifies potential leaders of the U.S. market, including Amgen, Hospira and Sandoz, among the top three pharmaceutical companies with the most potential to dominate the early stages of biosimilar medications entering the U.S. (bio-medicine.org)
Meanwhile, on March 6, 2015, the FDA approved the United States's first biosimilar product, the biosimilar of filgrastim called filgrastim-sndz (trade name Zarxio) by Sandoz. (wikipedia.org)
In Europe, Sandoz can launch Humira biosimilar from Oct 16. (zacks.com)
Biosimilars can help people suffering from chronic, debilitating conditions gain expanded access to important medicines that may change the outcome of their disease," said Stefan Hendriks, Global Head of Biopharmaceuticals, Sandoz. (novartis.com)
Sandoz is well-positioned to lead the biosimilars industry based on its experience and capabilities in development, manufacturing and commercialization. (novartis.com)
Meanwhile, Amgen and Sandoz, the generic unit of Novartis, are fighting interpretation of a federal law that says a brand-name company is entitled to receive 180-day notice from a drug maker that wants to sell a biosimilar. (statnews.com)
Novartis division Sandoz has gotten acceptance for its biosimilar to Amgen's Neulasta by the European Medicines Agency (EMA) for regulatory review, Novartis said on Friday. (pharmaceuticaldaily.com)
Pegfilgrastim is a long-acting formulation of filgrastim (granulocyte colony-stimulating factor, or G-CSF) and Sandoz is seeking approval for use of its biosimilar in the same indication as the reference medicine. (pharmaceuticaldaily.com)
As the global leader in biosimilars, Sandoz has five biosimilars marketed worldwide, as well as a leading global pipeline. (pharmaceuticaldaily.com)
As Amgen notes in its complaint, the Federal Circuit held in Amgen v. Sandoz that notice cannot be given before the biosimilar is approved. (foley.com)
But, Sandoz has requested rehearing en banc of that finding, so the issue may not yet be finally resolved. (foley.com)
The CHMP opinion recommends the proposed Sandoz biosimilar infliximab for the treatment of all indications of its reference medicine across gastroenterology, rheumatology and dermatology. (pharmaceuticaldaily.com)
Sandoz is proud to be at the forefront of diversifying the biologics treatment landscape by bringing biosimilar medicines to market for patients living with devastating autoimmune diseases," said Richard Francis, CEO, Sandoz. (pharmaceuticaldaily.com)
The clinical Phase III confirmatory study in rheumatoid arthritis (REFLECTIONS B537-02) met its primary endpoint, demonstrating equivalent efficacy of proposed Sandoz biosimilar infliximab to the reference medicine as measured by the American College of Rheumatology 20 (ACR20) response at Week 14. (pharmaceuticaldaily.com)
Holzkirchen (GLOBE NEWSWIRE) - Sandoz, a Novartis division and the pioneer and global leader in biosimilars, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for marketing authorization of its proposed biosimilar pegfilgrastim,®*** a long-acting version of supportive oncology care medicine filgrastim. (ecmconnection.com)
Sandoz is committed to increasing patient access to high-quality biosimilars, with five marketed and seven approved biosimilars in Europe. (ecmconnection.com)
Sandoz is seeking approval for use of biosimilar pegfilgrastim in the same indication as the reference medicine, for the prevention of chemotherapy-induced infection, known as febrile neutropenia, which includes fever brought on by low neutrophils (a specific type of white blood cells). (ecmconnection.com)
The comprehensive data package, submitted as part of the Marketing Authorization Application, includes analytical, preclinical, and clinical data, which demonstrate that Sandoz biosimilar pegfilgrastim matches the reference medicine in terms of safety, efficacy and quality . (ecmconnection.com)
With the FDA acceptance of our regulatory submission for proposed biosimilar rituximab, we plan to deliver patients a high-quality Sandoz biosimilar that, following approval, could help drive healthcare savings and increase competition, while freeing up resources for and supporting patient access in other areas of cancer care including innovative therapies. (pharmiweb.com)
Sandoz believes these data provide confirmation that the proposed biosimilar matches the reference medicine in terms of safety, efficacy and quality. (pharmiweb.com)
Sandoz is committed to increasing patient access to high-quality biosimilars. (pharmiweb.com)
Sandoz also continues to champion policy and legislation that enables patients and the healthcare system to benefit from biosimilars. (pharmiweb.com)

Dr. Michel Mikhail has more than 30 years Pharmaceutical Industry experience and track record of achievement in R & D and International Regulatory Affairs in large multinational Research-based pharmaceutical Companies, Biotech Companies as well as in the Generics industry. (smi-online.co.uk)
Dr. Mikhail is a Global Expert in Biosimilars and International Regulatory Affairs Expert. (smi-online.co.uk)
These and other prominent regulatory, legal and research issues were addressed by representatives of innovator firms and biosimilar makers, as well as patient advocates, payers and providers, at a recent FDA public hearing on competition and innovation in the biological products marketplace. (pharmexec.com)
With its global collaborations, a fully integrated monoclonal antibody development platform and global standard GMP biotechnology manufacturing facility, Turgut Pharmaceuticals is the leading biotech company in Turkey with the vision to develop high-quality biosimilars that meet the strict regulatory requirements of highly regulated markets such as Europe and the United States. (selexis.com)
We look forward to progressing M923 toward regulatory approval and commercialization with our collaborative partner Baxalta and to the potential of providing a more affordable biosimilar option for the many patients suffering from chronic autoimmune and inflammatory diseases. (cnbc.com)
This release includes forward-looking statements concerning M923, a proposed biosimilar of HUMIRA, including expectations with regard to clinical trials, future regulatory actions and commercialization plans, and its potential impact on patients. (cnbc.com)
Celltrion received FDA and EMA approval for Inflectra® and Remsima®, respectively, which is the world's first biosimilar mAb to receive approval from a regulatory agency in a developed country. (businesswire.com)
Detailed analysis of the emerging regulatory framework in regulated markets as well as comparisons of biosimilar guidelines in Europe, the U.S., Japan, Canada, and the guidelines developed by WHO. (bccresearch.com)
This article will present an overview of the regulatory requirements for approval, extrapolation of indication, emerging biosimilar mAbs, and potential limitations to the uptake of biosimilars in clinical cancer therapy. (uspharmacist.com)
Regulatory requirements for the approval of biosimilars in guidelines of the European Medicines Agency (EMA), the FDA, and the World Health Organization (WHO) are science-based and similar. (uspharmacist.com)
The European regulatory authorities led with a specially adapted approval procedure to authorize subsequent versions of previously approved biologics, termed "similar biological medicinal products", or biosimilars. (wikipedia.org)
The regulatory approval for biosimilar Trastuzumab in India is the world's first biosimilar version under the brand name of CANMAb. (prnewswire.co.uk)
The study analyzes the changing dynamics of the pharmaceutical market and provides insight into the regulatory pathways for branded pharmaceuticals and biologics, patent expirations, business strategies, clinical trials and drug applications. (bio-medicine.org)
Resistance to biosimilars could seem like noise to prop up patented drugs, but Peter Pitts, president of the Center for Medicine in the Public Interest and a former FDA associate commissioner, says "there are many issues," that could be factors in why a regulatory pathway wouldn't necessarily start a flood of look-alike drugs. (mmm-online.com)
There are numerous development and regulatory constraints associated with biosimilar development affecting decision of commercialization. (omicsonline.org)
It is important to optimize commercialization strategies as regulations are still evolving hence it is vital for the companies to quickly modify biosimilar development strategies matching with the regulatory scenario. (omicsonline.org)
There are unique development and commercialization challenges in biosimilar hence requiring detailed clinical development plan including better defined regulatory pathways and information about market access ( Figure 1 ) [ 1 - 4 ]. (omicsonline.org)
This paper reviews the literature on biosimilar drugs and covers their therapeutic status, clinical trials, approved biosimilars, and regulatory guidelines in Japan, South Korea, and Malaysia. (drugpatentwatch.com)
Biosimilars have been approved according to the established international regulatory standards (which the European Medicines Agency pioneered) and are demonstrated to be safe and efficacious . (pharmaceutical-journal.com)
Our industry has contributed to the biosimilar regulatory standards and we have set out support for biosimilars. (pharmaceutical-journal.com)
Legal disputes regarding originator biologic patents have impeded launches of biosimilars, some of which are stuck in patent purgatory for years following regulatory approval. (forbes.com)
How do biosimilars receive regulatory approval? (parexel.com)
Qualitative assessment tools such as PEST analysis, cost structure analysis and regulatory compliance for pharmaceutical products are offered in the report. (pharmiweb.com)
RAND research on pharmaceuticals examines their safety and effectiveness, relevant health economics issues, prescription drug abuse, challenges related to access and adherence, and pharmaceutical regulatory policy. (rand.org)
1 The Biologics Price Competition and Innovation Act (BPCIA) of 2009, which was passed as part of the health care reform legislation enacted into law in 2010, authorizes the FDA to establish a long-awaited regulatory pathway for biosimilars. (ptcommunity.com)
3 , 4 Ideally, the FDA's finalized guidelines will establish a regulatory path for biosimilars that will ensure patient safety, control development costs, and encourage innovation by manufacturers. (ptcommunity.com)
All attendees will be given a USB drive containing over 200 current and draft global regulatory and quality guidance documents associated with the development and commercialisation of biotech and biosimilar products. (cpduk.co.uk)
Our years of experience in pharmaceutical matters, our strong technical/scientific experience, and our knowledge and understanding of the patent and regulatory laws position our team to address the most complex and challenging intellectual property issues facing our clients in the biosimilar industry. (haynesboone.com)
These biosimilar drugs can only be approved for the indications and conditions that have been previously approved for the reference product by big regulatory agencies. (sbwire.com)
On the other hand, high manufacturing complexities and costs, stringent regulatory requirements in countries and operational challenges are restricting the growth of the biosimilars market. (reportbuyer.com)
Demand for biosimilars is high in European countries as compared to other regions owing to availability of well-developed regulatory framework coupled with presence of a large number of biopharmaceutical companies. (grandviewresearch.com)
Over the past decade, several publications have examined the scientific, legal and regulatory aspects of biosimilar development. (bmj.com)
Leveraging these hands-on government and industry experiences, Mr. Chen effectively assists multinational and Chinese pharmaceutical, biotechnology, medical device, food, and cosmetic companies and trade associations to address the most pressing regulatory law issues confronting business. (cov.com)

European regulators have issued a green light for Amgen and Allergan's Mvasi, marking the first biosimilar of Roche's Avastin to be approved in the region. (pharmatimes.com)
Mvasi is the first product borne out of an alliance between Amgen and Allergan to bag marketing authorisation from the European Commission, "highlighting the success of our joint commitment to developing cancer biosimilars," noted David Nicholson, chief research and development officer at Allergan. (pharmatimes.com)
Pharmaceutical companies presenting included Amgen, Inc. (fiercebiotech.com)
Amgen, Mylan and Samsung Bioepis' biosimilar versions are expected to be launched in the United States in January, June and July 2023, respectively while in the EU, Amgen and Biogen's biosimilars are expected to be launched this month. (zacks.com)
THOUSAND OAKS, Calif. and PARSIPPANY, N.J. , Dec. 19, 2011 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and Watson Pharmaceuticals, Inc. (NYSE:WPI) announced today that they will collaborate to develop and commercialize, on a worldwide basis, several oncology antibody biosimilar medicines. (amgen.com)
The collaboration will not pursue biosimilars of Amgen 's proprietary products. (amgen.com)
Biosimilars provide an exciting long-term growth opportunity for Amgen. (amgen.com)
Several companies such as Amgen, Boehringer Ingelheim, and Pfizer are focusing on development of biosimilar drug of rituximab. (medindia.net)
Patent clocks are ticking regardless, and both patented biologics owners like Roche and Amgen, and biosimilars contenders Eli Lilly and Novartis are pins-and-needling their way to the finish line. (mmm-online.com)
Amgen has filed a complaint under the Biologics Price Competition and Innovation Act (BPCIA), asserting that a biosimilar application filed by Apotex, Inc. infringes two of its patents. (foley.com)
Although Amgen and Apotex cooperated in the biosimilar patent dance, it appears that they disagree on the notice requirements of 42 U.S.C. § 262(l)(8)(A). According to Amgen, Apotex "purport[ed]" to give notice on April 17, 2015, even though its product had (and has) not yet been approved. (foley.com)
The lower court decision had ruled in favor of Amgen, preventing Novartis from releasing its biosimilar until six months after the Food and Drug Administration approved it. (bioethics.net)
Amgen, the possible loser as a result of Friday's approval, has a biosimilars pipeline that includes lookalikes of AbbVie's Humira and Roche's Avastin. (mmm-online.com)
In an October 2014 business review Amgen projected that its lineup of nine biosimilar contenders could earn $3 billion in annual sales were they all to reach market. (mmm-online.com)
Amgen CEO Robert Bradway told investors during a Jan. 27 conference call that its 2015 earnings projections assumed Novartis's biosimilar could eat into sales of Neupogen. (mmm-online.com)
During the October presentation Amgen said one way to get doctors to trust biosimilars is to bring the company, not the brand, to the fore to make doctors comfortable with the firm's "deep biologics scientific skills and strong biologics manufacturing heritage. (mmm-online.com)

The UK's National Health Service (NHS) is dragging their heels in recommending the biosimilar form of the drug Remicade, according to Napp Pharmaceuticals. (xtalks.com)
According to the pharmaceutical developer, the NHS could save £90 million if it switched all patients currently taking Remicade (infliximab), to its biosimilar. (xtalks.com)
Remsima - Napp Pharmaceuticals' biosimilar of Remicade - is also in competition with a biosimilar called Inflectra, which was developed by Hospira. (xtalks.com)
Pfizer has obtained approval from the US Food and Drug Administration (FDA) for its IXIFI (PF-06438179, infliximab-qbtx) as a biosimilar to Remicade (infliximab) for all eligible indications. (pharmaceutical-technology.com)
Ixifi is Pfizer's second Remicade biosimilar that has been approved in the US, as Pfizer markets Celltrion's Inflectra (Remicade biosimilar) in the US. (pharmaceutical-technology.com)
Pfizer now faces the task of strategically marketing Ixifi and Inflectra to compete with Remicade (infliximab) and other approved Remicade biosimilars, including Biogen/Samsung Bioepis' Renflexis, in the UC space. (pharmaceutical-technology.com)
That being said, the approval of Pfizer's second Remicade biosimilar marks a win for the company in the UC space, with the potential to steal substantial market share from Remicade. (pharmaceutical-technology.com)
With the approval of Ixifi and the increased reputation of Inflectra, it is likely that Pfizer will hold a significant share of the revenue from biosimilar erosion of Remicade in UC. (pharmaceutical-technology.com)
US regulators have approved Renflexis, a biosimilar referencing Johnson & Johnson's tumour necrosis factor (TNF) blocker Remicade (infliximab), across all eligible indications. (pharmatimes.com)
The South Korean company already sells a biosimilar version of Remicade, a widely used antibody drug for treating rheumatoid arthritis, in Europe, Japan, and elsewhere. (statnews.com)
The distorted payer incentives for Remicade (infliximab) and biosimilar infliximab products illustrate some of the key challenges facing biosimilars. (forbes.com)
And things haven't changed as of this year, as 60% of payers prefer Remicade over biosimilars, a preference often expressed in terms of step edits for biosimilars. (forbes.com)
Only 5% of payers placed biosimilars in preferred tiers over Remicade. (forbes.com)
Drivers for the Remicade biosimilar include rising incidence of autoimmune diseases particularly rheumatoid arthritis and plaque psoriasis, early patent expiry of the branded version, discounted pricing across the European market and faster reaction times due to intravenous mode of administration. (sbwire.com)
Barriers of the Remicade biosimilar include serious side effects associated with the use of drug that could lead to hospitalization or even be fatal. (sbwire.com)
The Remicade (infliximab) biosimilar market is segmented based on approved disease indications and regions. (sbwire.com)
Early loss of patent exclusivity is one the major factors that could fuel attractive market growth of the Remicade biosimilar over the forthcoming years. (sbwire.com)
Rising prevalence of relevant autoimmune disorders coupled with discounted pricing of the Remicade biosimilar in European markets are factors expected to contribute to increased referral and consumption of the drug. (sbwire.com)
Depending on geographic regions, global Remicade biosimilar market is segmented into seven key regions: North America, South America, Eastern Europe, Western Europe, Asia Pacific excluding Japan, Japan and Middle East & Africa. (sbwire.com)
The psoriasis treatment market is facing increasing competitive pressure from a wave of biosimilar launches such as biosimilars of Janssen's Remicade, and Amgen's Enbrel with the impact of the headwinds expected to be more pronounced in the next few years. (giiresearch.com)

CT-P10 is claimed to be the world's first monoclonal antibody (mAb) biosimilar secured approval from the European Commission (EC) to treat oncology. (pharmaceutical-business-review.com)
Teva is pleased to announce this important milestone today, with our partner Celltrion, bringing us one step closer to making additional biosimilar treatment options available to patients in the U.S.," said Paul Rittman, Senior Vice President and General Manager, Teva Oncology. (businesswire.com)
Biosimilars are of growing importance to the oncology community and the approval of HERZUMA may provide more patients access to this important therapy," stated Woosung Kee, Chief Executive Officer of Celltrion. (tevapharm.com)
This is our second oncology biosimilar approval in the United States in the past month, which reinforces the goal for all of our approved products -- providing broader treatment options for patients and the providers who treat them. (tevapharm.com)
The addition of HERZUMA to our biosimilars portfolio will allow us to leverage our strengths from Oncology and Generics. (tevapharm.com)
It is important for oncology practitioners to be knowledgeable about current biosimilars and those in development for cancer treatment in order to provide guidance and make an informed decision when incorporating these drugs into clinical practice. (uspharmacist.com)
Additional biosimilars for oncology and immunology indications are expected to launch globally across major regions by 2020. (novartis.com)
Take an example of oncology which is one of the large areas of biosimilar drugs for cancer research. (indiatimes.com)
Oncobiologics is a privately-held biopharmaceutical company developing a pipeline of biosimilars and next generation biotherapeutics focused on clinically validated targets in the therapeutic areas of oncology, immuno-oncology, and immunology. (nimitfinance.com)
Among various application segments of biosimilar market, blood disorders and oncology together accounted for over 55% share of the global biosimilars market in 2015. (reportbuyer.com)

On Feb. 5, 2020, Merck announced that it intends to spin-off products from its Women's Health, trusted Legacy Brands and Biosimilars businesses, including ONTRUZANT, into a new, independent, publicly-traded company. (pharmaceutical-business-review.com)
Senior principal of Symphony Health Solutions' inThought Research, Claudia Wiatr, told MM&M "everybody has an estimate of how big the biosimilars market is going to be" but that pricing dynamics and payer demands probably mean that the US biosimilars market will be worth "anywhere from $10-20 billion by 2020. (mmm-online.com)
However, with the aggressive government support, and the increasing focus on biosimilars development, the government aims that the country would occupy a significant share of the global market for biosimilars by 2020. (pitchengine.com)
But IMS forecasts that biosimilars may save health systems in the European Union and the US anywhere from $50 billion to $110 billion by 2020. (statnews.com)
The best part is right now, only 10% of that is coming from biosimilars but by 2020 that is going to be $30 billion or $50 billion and the assumption is that by 2030 the numbers can catapult to $100 billion. (indiatimes.com)
The global biosimilars market is predicted to cross US$ 25 Billion mark by 2020. (reportbuyer.com)
LONDON , June 19, 2020 /PRNewswire/ -- The production of new insulin biosimilars is trending in the biosimilars market, being produced to treat both type 1 and type 2 diabetes. (prnewswire.com)

Factors driving the increase of this market include growing demand for biosimilar drugs due to their cost-effectiveness, growing incidence of chronic diseases, and strategic collaborations resulting in enhanced productivity and clinical trial activities. (smi-online.co.uk)
With the expiry dates of major patents fast approaching, the emerging gap in the market for biosimilars is now a major attraction for manufacturers. (smi-online.co.uk)
As the availability of biosimilars could potentially reduce direct spending by USD$54B by 2026, the question is what can current biosimilar producing companies do to join this market to benefit the patients, physicians and investors? (smi-online.co.uk)
The focus of the talk will include the core strategic focus areas for biosimilar uptake, and a longer-term view on the criticality of a sustainable market. (smi-online.co.uk)
This report primarily focuses on Biosimilar Drug in the global market. (medgadget.com)
This report mainly covers Biosimilar Drug market in North America, Biosimilar Drug market in Europe, Biosimilar Drug market in Asia-Pacific, Biosimilar Drug market in Latin America, Middle as well as Africa. (medgadget.com)
This report partitions the Biosimilar Drug market based on Type, Manufacturers, Regions, and Application. (medgadget.com)
Global Biosimilar Drug market report also includes Manufacturers Profiles in Biosimilar Drug Market with their Business Overview. (medgadget.com)
It also includes Biosimilar Drug market by Type and Applications, Biosimilar Drug Price, Revenue, Sales and Biosimilar Drug Business Share. (medgadget.com)
Report on (Biosimilar Drug Market Report) mainly covers 10 Section acutely display the global Biosimilar Drug market. (medgadget.com)
The Association for Assessable Medicine (AAM) says evidence from several studies suggests that an increased entry of biosimilars into the market could save $42 billion to $108 billion over a 10-year period. (thebalance.com)
Due to increased competition with the accelerated approvals of biosimilars and their rapid introduction to the marketplace, market conditions will have to evolve to adapt. (thebalance.com)
Teva Pharmaceutical Industries announced Tuesday a partnership with Lonza Group to establish a joint venture to develop, manufacture and market biosimilars. (drugstorenews.com)
We had identified biosimilars as a major growth driver for Teva in our long-term strategy and have been augmenting our knowledge base, capabilities and infrastructure to position Teva as a leader in this market," Teva president and CEO Shlomo Yanai said in a statement. (drugstorenews.com)
KOLs noted that the cost of using TNF alpha inhibitors is high and believe that the introduction of more cost-effective biosimilars is needed in the market to drive down the prices of these therapies. (pharmaceutical-technology.com)
Although FDA has approved a dozen biosimilar products, only four are available to patients due largely to patent and competitive issues that block market access. (pharmexec.com)
PHILADELPHIA , May 14, 2013 /PRNewswire/ -- The IP & Science business of Thomson Reuters , the world's leading provider of intelligent information for businesses and professionals, today announced the release of a life sciences report, " An Outlook on U.S. Biosimilar Competition ," providing a comprehensive view of the challenges facing companies entering the United States biosimilar drug market and key players predicted to break into this developing pharmaceutical space. (bio-medicine.org)
While the U.S. continues to take steps toward entering the global biosimilar market, it lags behind other nations in this space. (bio-medicine.org)
In this context, this paper explores the movement of Indian pharmaceutical firms from 'small molecule generics' towards targeting a new set of opportunities presented by the emergent biosimilar segment in the global generics market. (open.ac.uk)
Leading pharmaceutical and drug manufacturing companies from developed countries are investing substantially in R&D, infrastructure and new technologies in ophthalmology therapeutics to capture significant market share. (pharmaceutical-business-review.com)
Americas active pharmaceutical ingredients (API) market revenue held a share of around 42.5% of global API market revenue of 108.6 $ billion in 2011. (marketresearchreports.biz)
Detailed historical, forecast trend and share analysis of API revenue based on customer base (Generic and Innovative for Synthetic APIs) (Biosimilars and biologics for Biotech Apis) in the Americas market and in key countries of the region. (marketresearchreports.biz)
The success we've seen with Turgut to date fuels our collaboration and we are excited to continue to support their efforts to bring biosimilars to the market under these new agreements. (selexis.com)
The drug was cleared in the US in September last year, where it was also the first biosimilar of Roche/Genentech's mega blockbuster to reach the market. (pharmatimes.com)
The current role of the pharmaceutical industry's sales and marketing workforce will be replaced by a new model as the industry shifts from a mass-market to a target-market approach to increase revenue. (coalesceresearchgroup.com)
The Indian pharmaceuticals market , along with the markets of China, Brazil and Russia, will spearhead growth within these markets. (coalesceresearchgroup.com)
Pricing information is not yet available, but biosimilars are generally coming onto the market at up to 30 percent less than their reference products. (pharmatimes.com)
The global biosimilars market is expected to reach $35 billion by 2030. (ibc-asia.com)
Biosimilars market potential - what can we achieve? (ibc-asia.com)
Changing Landscape of Global Biosimilars Market and What it Means for China? (ibc-asia.com)
The global biosimilars market was valued at $1.8 billion in 2013 and nearly $2.0 billion in 2014. (bccresearch.com)
An overview of the global market for biosimilars. (bccresearch.com)
This report is a comprehensive study on the demand for biosimilar drugs that have entered the market worldwide. (bccresearch.com)
Launch of biosimilars in the erythropoietin market has increased its affordability. (prnewswire.co.uk)
European region is the largest market for erythropoietin biosimilar, which makes it a major market for over all erythropoietin drugs as well. (prnewswire.co.uk)
Based on segment, the report sub-divides the market into biologics and biosimilar. (prnewswire.co.uk)
However, biosimilar market is poised to witness the highest growth due to their cost effectiveness. (prnewswire.co.uk)
In the last two years, the introduction of a handful of biosimilars to the pharmaceutical market increased competition and drove down the cost of some biologics. (rand.org)
This book analyses the context of biotechnological production and addresses the European legal framework for biosimilar market approval. (ebooks.com)
Market Research Reports: Biologics, Biosimilars, Bioseparation Systems for Biopharmaceutic. (bio-medicine.org)
Blockbuster biologics are going off patent, leaving the market open for developing and manufacturing low cost biosimilars. (bio-medicine.org)
Furthermore, lower cost of biosimilars compared to patented biologics and positive outcomes in clinical trials are expected to boost market growth. (medindia.net)
A large reason for the shortfall between US biosimilars market estimates and the branded market totals is that the biologics-biosimilars discount won't be as wide as the one between small-molecule branded drugs and their generics. (mmm-online.com)
Market for the biosimilar is growing in faster pace and development is currently at peak. (omicsonline.org)
Offering the advantages of favorable government and business conducive environment, the South Korean biosimilars market is poised for significant and rapid growth in the future years. (pitchengine.com)
Thus, with all the government policies and frameworks, the biosimilars market in South Korea has become the growth engine of the country attracting huge investments from public and private companies located in and outside Korea. (pitchengine.com)
While Roche and Genentech keep raising prices in the US, they engage in predatory pricing in Russia, where (they) sell such drugs at a loss - all to destroy (Biocad) and prevent it from entering the US market with cheaper biosimilars," the Russian company contended. (statnews.com)
The allegations emerge at a time when the biosimilar market is forecast to become a fast-growing and lucrative chunk of the US pharmaceutical industry. (statnews.com)
According to Amgen's complaint filed in the U.S. District Court for the Southern District of Florida, Apotex filed a Biologic License Application (BLA) seeking FDA approval to market a biosimilar version of Amgen's Neulasta® (pegfilgrastim) product. (foley.com)
However, the emerging competitive biosimilar market looks to be vastly different than the generic one. (fiercepharma.com)
In Europe, where biosimilars have been on the market for nearly a decade, sales have been disappointing. (xconomy.com)
And, the market share percentage for the marketed biosimilars has struggled to get out of single-digit territory. (forbes.com)
India has risen from the 15th largest pharmaceutical market in 2007 to 12th in 2011 and is expected to become the 8th largest by 2015. (lexology.com)
In fact, India's pharmaceutical market has a compound annual growth rate of 12% post price controls. (lexology.com)
Biosimilar Market is expected to reach an estimated USD 3. (pharmiweb.com)
The report analyses the recent drug approval trends and market dynamics such as drivers, restrains, and opportunities, industry trends and future outlook in the Global Biosimilar Market. (pharmiweb.com)
What is the market drivers, restrains, opportunities governing the Global Biosimilar Market? (pharmiweb.com)
Which are the largest and the fastest growing segments in the Global Biosimilar Market? (pharmiweb.com)
The growth in the market is attributed to the growing demand of biosimilars for the treatment of various diseases such as cancer, rheumatoid, crohnrsquo;s disease, and psoriatic arthritis, among others. (pharmiweb.com)
Moreover, increasing investment in research and development activities coupled with favorable policies to accelerate approvals of biosimilar drugs and lower cost of the biosimilar products are also boosting the market growth. (pharmiweb.com)
The Global Biosimilars Treatment Market Size, Status and Forecast 2022 has been projected in a market intelligence report published by MarketResearchReports.Biz. (sbwire.com)
The study examines the main factors that are influencing the growth of the worldwide Global Biosimilars Treatment Market thoroughly in order to estimate the overall value and the size of this market over the next few years. (sbwire.com)
This report studies the global Biosimilars Treatment market, analyzes and researches the Biosimilars Treatment development status and forecast in United States, EU, Japan, China, India and Southeast Asia. (sbwire.com)
This report breaks down the capability of Biosimilar Monoclonal Antibodies market in the present and in addition the future prospects from different points in detail. (webnewswire.com)
Further, the Biosimilar Monoclonal Antibodies report gives data on the organization profile, piece of the pie and contact subtle elements alongside esteem chain investigation of Biosimilar Monoclonal Antibodies industry, Biosimilar Monoclonal Antibodies industry tenets and arrangements, conditions driving the development of the market and impulse hindering the development. (webnewswire.com)
Biosimilar Monoclonal Antibodies Market improvement scope and different business procedures are additionally specified in this report. (webnewswire.com)
The Biosimilar Monoclonal Antibodies look into report incorporates the items that are right now sought after and accessible in the market alongside their cost separation, producing volume, import/send out plan and commitment to the Biosimilar Monoclonal Antibodies advertise income around the world. (webnewswire.com)
At last, Biosimilar Monoclonal Antibodies advertise report gives you insights about the statistical surveying discoveries and conclusion which causes you to create productive market systems to increase upper hand. (webnewswire.com)
This Biosimilar Monoclonal Antibodies market study provides comprehensive data which enhances the understanding, scope and application of this report. (bioportfolio.com)
Despite this, it still took five years for the first biosimilar to be approved by the FDA, and there are only nine biosimilars available on the market in the US to date. (drugdevelopment-technology.com)
As a result of this slow entry into the market, it is estimated that only 3% of spending on biologics may face competition from biosimilars. (drugdevelopment-technology.com)
So why are biosimilars struggling to enter the market despite the BPCIA? (drugdevelopment-technology.com)
Without a meaningful education drive, biosimilars are likely to be dismissed as less effective than their reference products, which physicians are more experienced and comfortable using, and so the financial incentive for entering the biosimilar market is significantly reduced. (drugdevelopment-technology.com)
Moreover, manufacturers of the reference product often instigate 'pay-to-delay' schemes disguised as rebates or contracting provisions to PBMs to prevent the biosimilar entering the market. (drugdevelopment-technology.com)
In Europe, for example, which is 25% of the biopharmaceutical market, already 40% biosimilars have entered and in Japan also. (indiatimes.com)
However, United States have been very cautious and they have not been allowing the biosimilars to come in because they were like 50% of the biopharmaceutical market of the $250 billion. (indiatimes.com)
The scope of the agreement includes exclusive commercialization by Huahai of these four biosimilars developed by Oncobiologics and manufactured in China at a Huahai biologics facility for the China market. (nimitfinance.com)
2 These parameters will determine the ease and cost for a manufacturer to develop and market a biosimilar and will also ultimately influence the price of these medications. (ptcommunity.com)
Report any adverse reaction to a biosimilar insulin, as for a biologic insulin, to allow for post-market surveillance to take place. (diabetes.ca)
The major factor that is driving the market for biosimilars industry is the fact that major biologics are nearing the patent cliff. (reportbuyer.com)
The insulin and interferon product segment each accounted for single digit share of the global biosimilars market respectively in 2015. (reportbuyer.com)
The market for biosimilars in the U.S. has gained momentum after the launch of Novartis' Zarxio in September 2015. (reportbuyer.com)
In the European countries, Germany is at the forefront with around XX% share of the biosimilars market in 2015 followed by France with XX% share in the same year. (reportbuyer.com)
China accounted for XX% share of the global biosimilar market in 2015. (reportbuyer.com)
South Korea captured XX% of the global biosimilar market in 2015 being closely followed by Brazil with XX% share in the same year. (reportbuyer.com)
iGATE RESEARCH report titled "Global Biosimilars Market and Forecast (By Product Type, Applications, Country Wise & Companies) to 2021 and Biosimilars Approved & Pipeline Analysis" provides a comprehensive assessment of the fast-evolving, high-growth Global Biosimilars market. (reportbuyer.com)
As per reports in the Global Market Model , the key players operating in the biosimilars market are investing in creating biosimilars of insulin, which is promoting competition among various manufacturers. (prnewswire.com)
The biosimilars market consists of sales of biosimilars and related services that are used to treat chronic diseases such as diabetes, arthritis, and cancer. (prnewswire.com)
Therefore, the rise in the prevalence of chronic diseases is projected to propel the demand for biosimilars, driving the biosimilars market. (prnewswire.com)
Thus, the global biosimilars market is expected to grow from $7.79 billion in 2019 to $23.63 billion by 2023 at a significant rate of 31.7% . (prnewswire.com)
Cost-effectiveness of biosimilar drugs and high prevalence of chronic disorders globally are some major factors contributing to market growth. (grandviewresearch.com)
Thus, there is high demand for cost-effective biosimilars for the treatment of such chronic disorders, which, in turn is expected to boost market growth. (grandviewresearch.com)
Thus, efforts to bring down healthcare expenditures is projected to boost the market for biosimilars. (grandviewresearch.com)
Stringent government regulations for the development and production of biosimilars could hinder biosimilars market growth. (grandviewresearch.com)
European countries including Germany, U.K., and France have most favorable market conditions for biosimilars. (grandviewresearch.com)
The introduction of advanced mAbs is expected drive the global biosimilar monoclonal antibody market. (alliedmarketresearch.com)
The global biosimilar monoclonal antibody market is segmented on the basis of type, application, and geography. (alliedmarketresearch.com)
Biosimilars is also sometimes used to refer to biogenerics, including the ∼150 mostly lower-end "knock-offs" of established major-market innovator products not made to good manufacturing practice (GMP) standards and sold in lesser-regulated international markets. (bioprocessintl.com)
Uptake has been slow or negligible in nearly all European countries, however, with the total market for all EU biosimilars around US$400-$500 million at most. (bioprocessintl.com)
That equates to an average of about $40 million/year market for each product, an inadequate market by most pharmaceutical (and particularly, biopharmaceutical) standards. (bioprocessintl.com)
Overall, biosimilars have yet to make a real impact on the biopharmaceutical market. (bioprocessintl.com)
With the United States being the primary market for innovative pharmaceuticals and US payers fully expected to force rapid, widespread adoption of less-expensive biosimilar products, the country will be the most important market for biosimilars by far. (bioprocessintl.com)
Petrou P, Vandoros S. Cyprus in crisis: recent changes in the pharmaceutical market and options for further reforms without sacrificing access to or quality of treatment. (springer.com)
More biosimilars are being created each year, and the market for biosimilars will only continue to grow. (healthexchange.org)
It's important to note that there are still not that many biosimilars on the market as of yet. (healthexchange.org)
The market growth in psoriasis is driven by an upsurge in demand from new therapies in moderate to severe patient population which overshadows reduced pricing of branded TNF-α inhibitor and recent biosimilar launches. (giiresearch.com)
The Court heard oral arguments in regards to an appeal by Novartis, Swiss pharmaceutical company, requesting the time for biosimilars to be on the market be sped up. (bioethics.net)
The FDA's first-ever biosimilar approval on Friday is a watershed moment for the healthcare system, with pharma companies seeking to capitalize on the new opportunity in the US biologics market, which garnered $1 billion in sales in 2013. (mmm-online.com)
Amgen's Neupogen (filgrastim) will be the test case for the US's biosimilars market now that the FDA approved Sandoz's lookalike version of the branded biologic, almost two months after a unanimous FDA panel endorsement. (mmm-online.com)
Even with the FDA's endorsement and cost-savings arguments, like Rand Corp.'s prediction that the overall biosimilars market could result in $44.2 billion in savings between 2014 and 2024, or 4% of what the US spends on biologics, makers of biosimilars have to convince doctors the drugs are worthwhile. (mmm-online.com)

In addition, the firm's portfolio includes a biosimilars pipeline with 13 distinct biosimilar molecules that are in different stages of development. (pharmaceutical-technology.com)
In just under three years, we've signed five commercial license agreements collaborating with the Turgut team to advance its pipeline of high-quality biosimilars. (selexis.com)
A look at biosimilar product classes in various regions worldwide, as well as the worldwide pipeline for biosimilars. (bccresearch.com)
And even though just one biosimilar has so far been approved in the United States, the industry pipeline is growing. (statnews.com)
The Herceptin (Trastuzumab) Biosimilar Clinical Trial Insight report gives comprehensive clinical insight on 37 biosimilar version of Herceptin drug in clinical pipeline. (prnewswire.co.uk)
We are talking about a trillion dollar of pharmaceuticals and 75% of the pipeline drugs going to be biological drugs and what does that mean? (indiatimes.com)
Further, the lower cost of these drugs as compared to the patented biologics, the increasing encumbrance to curb healthcare costs globally, increasing nationwide government initiatives, and the strong pipeline for the biosimilar drugs is expected to fuel the biosimilars industry. (reportbuyer.com)

Interchangeability, automatic substitution and switching are key issues when treating patients with biosimilars in clinical practice. (nih.gov)
Biosimilars' interchangeability and conditions to be implemented. (ebooks.com)
In some counties, such as France or Spain, biosimilars are treated akin to innovator products with no interchangeability permitted, whereas in others, such as Germany, they more like generics with automatic substitution encouraged. (parexel.com)
Summarize interchangeability of biosimilars with reference biologics and how it impacts clinical practice. (neurosciencecme.com)
The FDA standard for interchangeability status has requirements that go beyond showing similarity between the biosimilar and the product it mirrors. (mmm-online.com)

We believe that our extensive analytical and biocharacterization work has allowed us to create a high-quality biosimilar candidate of HUMIRA," said Jim Roach, M.D., Senior Vice President of Development and Chief Medical Officer of Momenta Pharmaceuticals. (cnbc.com)
They are running studies designed to convince doctors and insurers that patients can be easily switched from expensive biologics - such as the arthritis treatments Humira and Enbrel - to so-called biosimilars, which are almost identical variants. (statnews.com)
Last year, AbbVie filed a citizen's petition with the US Food and Drug Administration to argue that biosimilars need distinct labeling in a bid to slow approval of biosimilar versions of its best-selling Humira rheumatoid arthritis treatment. (statnews.com)

Dan has over 20 years' experience in the pharma/biotech industry, ranging across multiple leadership and specialist roles, including both launch and life cycle management, in both originator and biosimilar markets. (smi-online.co.uk)
US KOLs also suggested that physicians are more likely to prescribe biosimilar products following the results of the NOR-SWITCH study, which demonstrated that Inflectra is safe and efficacious and has similar operating characteristics to the originator molecule. (pharmaceutical-technology.com)
Utilizing the SURE technology Platform, Selexis has successfully generated numerous biosimilars, including marketed products, that have glycan profiles matching originator products. (selexis.com)
Biosimilars have the same amino acid sequence and highly similar glycosylation patterns that overlap with the originator product. (nih.gov)
Physician preference-Since biosimilar are not like simple generics hence it's difficult to prove that drug is similar enough like originator. (omicsonline.org)
It is not easy to convenience multiple stakeholders to switch from originator to biosimilar unless having unique marketing strategy and significant cost difference. (omicsonline.org)
One of them, for example, is originator manufacturers giving substantial rebates to certain payers that cover the originator biologics but exclude competing biosimilars. (forbes.com)
The makers of originator biologics have fought tooth and nail to block biosimilars, with patent litigation, rebates to insurers, and exclusion contracts. (forbes.com)
However, it does not address the key question as to whether a biosimilar may be considered 'substitutable' (when a pharmacist can replace the originator biologic with the biosimilar with physician's consent) or 'interchangeable' (when a pharmacist can substitute the biosimilar without physician's consent, typical of generic products) with its reference biologic. (parexel.com)
These criteria have inspired debate and the emergence of several critical issues, such as to what extent the biosimilars pathway should be abbreviated, how much clinical data should be required for approval, or when an agent should be designated as comparable or interchangeable with an originator biologic. (ptcommunity.com)
Every manufacturer of biologics or biosimilars uses a unique cell line and a proprietary process to produce a particular biologic agent, so it is impossible to produce biosimilars that are identical to the originator drug. (ptcommunity.com)
5 The inability to produce an exact copy of an originator biologic is the reason for the term "biosimilar" rather than "biogeneric" or "bioidentical. (ptcommunity.com)
Biosimilar G-CSF resulted as effective and safe as originator filgrastim molecule in mobilizing PBSCs in children, with the advantage of a reduced cost. (wiley.com)
Thus, the new, biosimilar drug is a complex molecule of biologic origin, produced with different methods, not chemically identical to the originator. (wiley.com)
1 To make effective biologics more widely available, biosimilars of products that no longer are protected by patent have been developed and have been made available to patients at costs lower than those of the bio-originator. (bmj.com)
Rovi, a Spain-domiciled, speciality pharma company, plans to launch an enoxaparin biosimilar (originator: Sanofi Clexane/Lovenox) into key European markets by year end. (edisoninvestmentresearch.com)

Biosimilar makers seek more leeway to submit data from clinical trials of similar products approved in the Europe and other industrial countries. (pharmexec.com)
clinical trials are performed if uncertainty remains regarding safety and efficacy of the biosimilar. (coalesceresearchgroup.com)
Thus, as noted by the authors, clinician appraisal of and confidence in biosimilars will initially depend less on large clinical trials than on preclinical and pharmacologic data establishing bioequivalence and on their own clinical experience. (coalesceresearchgroup.com)
Literature review of manufacturing processes of biosimilars, differences and similarities between biosimilars and the reference product, approval pathways for biosimilars, challenges in clinical trial study design and available data from clinical trials. (nih.gov)
Direct evidence of safety and benefit from clinical trials, post-marketing pharmacoviligance and unequivocal identification of the product as a biosimilar are requirements before approval. (nih.gov)
Dr. Janet Woodcock , head of CDER at the FDA has stated that the 'current system of clinical trials is broken,' and the FDA will not approve a biosimilar based on a comparative efficacy testing if other attributes fail to compare. (prnewswire.com)
Research and Markets has announced the addition of the 'Herceptin (Trastuzumab) Biosimilar Clinical Trial Insight' clinical trials to their offering. (prnewswire.co.uk)
Traditional products are created through chemical process due to simple and well-defined structure & having small molecules (Molecular weight ~150 Daltons) hence it is easy to produce identical API unlike biosimilar having large molecule (Molecular weight ~150,000 Daltons having complex structure and structural variation) needs larger clinical trials. (omicsonline.org)
Five overarching principles and eight consensus recommendations were generated, encompassing considerations regarding clinical trials, immunogenicity, extrapolation of indications, switching between bio-originators and biosimilars and among biosimilars, and cost. (bmj.com)

Renflexis is the first Samsung Bioepis product approved for marketing in the country, but its infliximab biosimilar is already approved for marketing in 28 European Union member states as well as Norway, Liechtenstein, Iceland, Australia and Korea. (pharmatimes.com)

Outside the US, Pfizer markets three biosimilar medicines, INFLECTRA (infliximab), Retacrit (epoetin zeta) and Nivestim (filgrastim). (pharmaceutical-technology.com)
In addition, Pfizer recently filed a Citizen Petition with FDA seeking agency action to halt "misinformation" on biosimilar safety and use from reference product manufacturers. (pharmexec.com)
Pfizer cited false and misleading statements from innovators that suggest biosimilars are not as safe or effective as brands and have slowed prescribing and uptake of the new competitors. (pharmexec.com)

SMi Group are delighted to announce the 10th annual Biosimilars conference taking place on 25th and 26th of September 2019 in London, UK. (smi-online.co.uk)

Celltrion strives to provide more affordable biosimilar mAbs to patients who previously had limited access to advanced therapeutics. (businesswire.com)
BOSTON, Nov. 16, 2015 (GLOBE NEWSWIRE) -- EPIRUS Biopharmaceuticals, Inc. (Nasdaq:EPRS), a biopharmaceutical company focused on the global development and commercialization of biosimilar monoclonal antibodies (mAbs), today announced the completion of manufacturing process lock and readiness for initiation of its pivotal global registration study. (cnbc.com)
EPIRUS Biopharmaceuticals (Nasdaq:EPRS) is a biopharmaceutical company focused on the global development and commercialization of biosimilar monoclonal antibodies (mAbs). (cnbc.com)
Recently, interest in biosimilars has exploded with the advent of biosimilar monoclonal antibodies (mAbs). (parexel.com)
Biosimilar monoclonal antibodies (mAbs) are complex, large proteins of the biosimilar family used by the immune system to identify and neutralize foreign bodies, such as bacteria, viruses, and others. (alliedmarketresearch.com)

As the patents and exclusivity for many biologics are expiring, this has created the huge opportunity for the development and approval of biosimilars for many biopharmaceutical players including innovator generics and biotech companies. (coalesceresearchgroup.com)
Although it may be tempting to claim that the biopharmaceutical industry is aiming to discredit biosimilars, it is simply not the case. (pharmaceutical-journal.com)
Biosimilars or Follow-on biologics are terms used to describe officially approved subsequent versions of innovator biopharmaceutical products made by a different sponsor following patent and exclusivity expiry on the innovator product. (bioportfolio.com)
A biosimilar is a "biopharmaceutical that is genetically engineered, designed to be highly similar to an existing approved biologic product. (neurosciencecme.com)
The biosimilars are poised to capture an unprecedented position in the biopharmaceutical industry driven by an increased extent of adoption and growing investment and deal making activity globally. (reportbuyer.com)

There needs to be clear guidance and a robust system of accountability to drive faster adoption of biosimilar medicines at the clinical commissioning groups (CCG) and Hospital Trust level," he adds. (xtalks.com)
Biologic medicines, including biosimilars, are developed using living organisms instead of synthesized chemical compounds and are known to effectively treat a range of conditions including rheumatoid arthritis, metastatic breast cancer, non-Hodgkin lymphoma and anemia. (bio-medicine.org)
On June 27, 2013, Hospira's Inflectra (INX) was the first biosimilar monoclonal antibody to receive positive opinion from European Medicines Agency's Committee for Medicinal Products for Human Use for rheumatoid arthritis, inflammatory bowel disease and plaque psoriasis. (nih.gov)
In semi- and unregulated markets, various copies of biologics were sold for many years before the establishment of biosimilar guidelines by the European Medicines Agency (EMA). (bccresearch.com)
Preface: Christian K. Schneider is Chairman, CHMP of the Similar Biological (Biosimilar) Medicinal Products Working Party (BMWP), member of the European Medicines Agency( London, United Kingdom) and works at the Paul-Ehrlich-Institut, Federal Agency for Sera and Vaccines (Langen, Germany) and at the Centre for Experimental and Clinical Infection Research (Hannover, Germany). (ebooks.com)
The expiration of patent protection for many biological medicines has led to the development of biosimilars in many countries around the world. (drugpatentwatch.com)
Among the steps Roche took to undercut Biocad was to deliberately drop prices for three cancer medicines - Avastin, Herceptin, and Rituxan/MabThera - in Russia, where the company said it sells biosimilar versions, according to a lawsuit filed earlier this month in federal court in New York. (statnews.com)
The strategy was to financially weaken the Russian drug maker to the point where it would be unable to remain competitive and pursue development and sales of biosimilar medicines, according to the lawsuit, which claims Roche violated US antitrust laws. (statnews.com)
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for marketing authorization of Sandoz's infliximab, a proposed biosimilar to reference medicine infliximab. (pharmaceuticaldaily.com)
PSA believes a consensus Australian document on terminology and definitions relating to biological medicines (including biosimilar medicines) should be developed as a priority to promote accurate and common understanding of this subject. (psa.org.au)
By contrast, in Europe, the European Medicines Agency does not have the authority to designate biosimilars as interchangeable - this rests with the individual member states. (parexel.com)

Bayer HealthCare Pharmaceuticals, Inc. v. Watson Pharmaceuticals, Inc. Represented Watson in patent infringement action involving a generic version of Yaz® (drospirenone and ethinyl estradiol) oral contraceptive product. (crowell.com)
Whilst there is evidence to support that initiating patients on biosimilars as a first-line treatment or switching patients to biosimilars may save the NHS money, our customer research shows that there is still a lot of anxiety around their use from both patients and clinicians," commented Sarah Eglington, healthcare intelligence director of Binley's - a UK provider of healthcare intelligence products and services. (xtalks.com)
Competition from biosimilar therapies will help to lower the cost of these expensive treatments, thus helping to reduce healthcare costs and increase patient access. (bio-medicine.org)
or biosimilar "interchangeable" (therapeutic alternatives which can be directly substituted for the innovator product without consultation with the healthcare provider). (groundzerous.com)
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions used by approximately 200 million patients in 100 markets every day. (businesswire.com)
He added that, if approved, the company will look forward to supporting cancer patients, healthcare professionals and payors with its biosimilar pegfilgrastim. (pharmaceuticaldaily.com)
Further, entry of biosimilar version could provide financial relief on healthcare systems and improve patient's accessibility to essential medication. (sbwire.com)
Biosimilars are seen as the key weapon to curbing soaring healthcare costs globally. (reportbuyer.com)
Biosimilars are a relatively recent aspect of healthcare coverage. (healthexchange.org)

The US Food and Drug Administration's (FDA) advisory committee has recommended approval of Celltrion and Teva Pharmaceutical's biosimilar of Roche's blood cancer drug Rituxan (rituximab). (pharmaceutical-business-review.com)
If approved by the FDA, CT-P10, a proposed biosimilar to Rituxan, will be the first rituximab biosimilar to be approved in the United States for the three proposed indications. (pharmaceutical-business-review.com)
Expert opinion: Most available data for biosimilars in RA relate to tumor necrosis factor inhibitors (TNFi) and rituximab (an anti-CD20 monoclonal antibody). (nih.gov)

Napp Pharmaceuticals said in a statement, "This is in contrast to countries such as Denmark, where uptake at 5 months after launch was reported to be 90 percent. (xtalks.com)
While the above-mentioned barriers to biosimilar uptake are significant, distorted payer incentives may be the highest hurdle to overcome. (forbes.com)
As a result, biosimilar sponsors are unable to offer large patient volume-based rebates on their products and PBMs therefore try to limit biosimilar uptake so as to maintain rebate payments. (drugdevelopment-technology.com)

Biosimilars are expected to cost 10 percent to 30 percent less than brand-name biologics and are forecast to lower the US health care bill by $44 billion over the next several years, according to a 2014 report from the RAND Corporation. (statnews.com)

The late close of the information assurance or licenses for the greater part of them made open doors for the advancement of duplicate adaptations of unique biopharmaceuticals with comparative biologic movement (named biosimilars). (omicsonline.org)
Despite this heterogeneity, all biopharmaceuticals, including biosimilars, must maintain consistent quality and clinical performance throughout their lifecycle. (wikipedia.org)
A foundational step in biosimilar development is process development and manufacturing process lock to establish biosimilarity and manage long term cost of goods," said Amit Munshi, president and chief executive officer, EPIRUS Biopharmaceuticals. (cnbc.com)
Right now, we are talking about a trillion dollar of pharmaceuticals and we are talking $250 billion of biopharmaceuticals. (indiatimes.com)
Biosimilars are expected to have biologic activity similar to that of existing, approved biopharmaceuticals and comparable efficacy and safety based on a full assessment that includes analytical, preclinical, pharmacokinetics (PK), pharmacodynamics (PD), and clinical studies. (neurosciencecme.com)
Biosimilars may be defined as biopharmaceuticals slated for generic-drug-like, abbreviated, comparisons-based approvals through a formal biosimilar approval pathway in the United States, European Union, and/or other highly regulated and developed countries based on a demonstration of substantial (bio)similarity to a reference product. (bioprocessintl.com)
(bioprocessintl.com)

Currently 3 biosimilar version of Herceptin are commercially available in India and Iran for the treatment of Breast cancer. (prnewswire.co.uk)
In an interview with ET Now , Debayan Ghosh , Founder & President, Epygen Biotech , says in five years, biosimilars is going to throw up $60 billion in India alone. (indiatimes.com)
India is seen as a key player in the biosimilar space with an exceptionally high number of approvals granted in the last decade compared to the global average. (reportbuyer.com)

Standard FDA approval is good enough for physicians to write prescriptions, but only an " interchangeable " designation will enable pharmacists to substitute a biosimilar for a brand-name biologic without contacting doctors for permission first. (statnews.com)
But Zarxio was approved as a biosimilar, not as an interchangeable product, the FDA notes. (wikipedia.org)
In the US, the FDA can designate a biosimilar interchangeable, via a process that is more rigorous than that for standard (substitutable) biosimilar approval and which requires additional data. (parexel.com)
No biosimilar has attained interchangeable status to date. (parexel.com)
A biosimilar should not be considered as interchangeable with its reference biologic drug with no regard for the person or clinical context. (diabetes.ca)
The FDA only approved the drug as a biosimilar as opposed to approving it as a biosimilar and an interchangeable biologic. (mmm-online.com)

This document summarises the views of the Pharmaceutical Society of Australia (PSA) on the investigation of potential therapeutic value of and therefore possible medicinal uses for cannabis. (psa.org.au)
France) require biosimilars to be appraised by their Health Technology Assessment body in the same way as a new therapeutic agent, whereas still others (e.g. (parexel.com)
The availability of biosimilars is eagerly anticipated, because these agents are expected to improve affordability and promote wider and earlier access to critical, often lifesaving therapeutic interventions. (ptcommunity.com)
Biologics were a pivotal innovation by the pharmaceutical industry, because they successfully addressed previously unmet therapeutic needs. (ptcommunity.com)

Back in 2010, the FDA implemented the Biologics Price Competition and Innovation Act (BPCIA) as part of the Affordable Care Act (ACA), which created an abbreviated pathway for biosimilar drug approval. (drugdevelopment-technology.com)

An emerging issue is the claim by brands that switching patients to biosimilars may generate added costs. (pharmexec.com)
As a result, doctors have been hesitant to switch patients to biosimilars. (forbes.com)

It is an opportunity for organizations specializing in generics and biosimilars to grow their businesses rapidly. (thebalance.com)
Generics and biosimilars' substitution. (ebooks.com)
AMGN ) become an industry powerhouse-according to Simon Goeller, a McKinsey & Co. partner who specializes in generics and biosimilars. (xconomy.com)
Egypt issues draft guidelines for biosimilars, Generics and Biosimilars Initiative Online , 2013. (springer.com)

Celltrion 's CT-P10 is a proposed biosimilar to Biogen and Genentech USA Rituxan, and is currently secured approval in 47 countries across the world. (pharmaceutical-business-review.com)
As the global leader in biosimilars who brought Inflectra, the world's first mAb biosimilar approved by the FDA, to the U.S., we are pleased and honored to have this opportunity to once again work with the FDA on CT-P10," said Woo Sung Kee, Chief Executive Officer of Celltrion. (businesswire.com)

We are excited about building Teva's presence in biosimilars," said Brendan O'Grady, Executive Vice President and Head of North America Commercial at Teva. (tevapharm.com)

A biosimilar is a copy version of an approved original biological medicine whose data protection has expired. (nih.gov)
A biosimilar is a biological product that is shown to be highly similar to a licensed biological product (the reference product) with no clinically meaningful differences from the reference product in terms of purity, safety, or potency. (uspharmacist.com)
A biosimilar is a biological product that is approved based on data showing that it is highly similar to a biological product already approved by the FDA (reference product) and has no clinically meaningful differences in terms of safety, purity and potency (i.e., safety and effectiveness) from the reference product, in addition to meeting other criteria specified by law. (europeanpharmaceuticalreview.com)
Generally, a biological is "twenty times more expensive per patient than traditional small-molecule pharmaceuticals. (bioethics.net)

The U.S. FDA has now launched Remicade's biosimilar Inflectra, which is only the second biosimilar drug to be approved by the agency. (sbwire.com)

However, safety issues concerning manufacturing facilities along with potential side effects of drug consumption could hamper for acceptance of infliximab biosimilar over the long run. (sbwire.com)

Revenue Analysis for Biosimilars in U.S. (giiresearch.com)

Biosimilars present more challenges than conventional generics and their marketing approval is also much more complicated. (drugpatentwatch.com)
Part 2 will discuss the potential issues and challenges that P&T committees will face when evaluating biosimilars. (ptcommunity.com)
Farhat F., Othman A., el Karak F., Kattan J. Review and results of a survey about biosimilars prescription and challenges in the Middle East and North Africa region. (springer.com)

Together we turned Teva into a highly diversified global pharmaceutical company, with an expanded geographical footprint and additional lines of business. (drugstorenews.com)
Global pharmaceutical markets are in the midst of major discontinuities. (coalesceresearchgroup.com)
With the patents set to expire for a number of medications, interest related to the development of biosimilar agents has expanded for cost-saving benefits and global access. (uspharmacist.com)
New biosimilars are driving the increase in global biomanufacturing capacity. (bio-medicine.org)
South Korea has emerged as one of the strategic location for the development of biosimilars on the global level. (pitchengine.com)
The South Korean Government has announced its plans to promote the biosimilars industry and make huge investments in the industry so as to make Korea a dominant player in the global marketplace. (pitchengine.com)
At present, the share of South Korea in the global biosimilars development is extremely meager. (pitchengine.com)
As the pioneer and global leader in biosimilars, this settlement helps remove uncertainty regarding when our biosimilar will be available. (novartis.com)

4-6 The approval of "biosimilarity" is based on the comparison of the proposed biosimilar to the reference product with respect to structure, function, animal toxicity, human pharmacokinetics and pharmacodynamics, clinical immunogenicity, clinical safety, and efficacy. (uspharmacist.com)

and Mylan N.V are some of the companies focusing on the development and production of biosimilars. (medindia.net)
Mylan Pharmaceuticals Inc. (drugpatentwatch.com)

Hence, the reason the approval process for biosimilars is so rigorous. (uspharmacist.com)

Over the past years, several biosimilars have been approved such as erythropoietin or growth factors. (nih.gov)
Biosimilar versions of various molecules including epoetins, insulins, somatropins, growth hormones, and follitropins have existed for several years in many markets. (parexel.com)

Merck announced the US launch of ONTRUZANT (trastuzumab-dttb), as a biosimilar of the reference biologic medicine Herceptin. (pharmaceutical-business-review.com)
Work together across the health care team to support patients who transition from a reference biologic drug to a biosimilar insulin, and to track the clinical outcomes associated with switching. (diabetes.ca)
Do not implement forced non-medical switching policies that require patients established on treatment to switch from a reference biologic drug to a biosimilar insulin. (diabetes.ca)

The world took notice of biosimilars when Biocon got that approval. (indiatimes.com)

In the United States, the first biosimilar to be approved was filgrastim, a human granulocyte colony-stimulating factor. (neurosciencecme.com)
Recently biosimilars of granulocyte-colony-stimulating factor (G-CSF) became available for prophylaxis and treatment of postchemotherapy neutropenia and for mobilization of peripheral blood CD34+ cells for either autologous or allogeneic hematopoietic stem cell transplant. (wiley.com)

One is physicians' caution when switching patients who have been on a "branded" drug to a biosimilar, Goeller says. (xconomy.com)
Provide sufficient information and support to patients and request informed consent to switch from a biologic drug to a biosimilar insulin. (diabetes.ca)

Final approval is based on one or more comparative clinical studies within a suitable clinical setting with at least one study that assesses immunogenicity, pharmacokinetics, or pharmacodynamics that demonstrate safety, purity, and clinical efficacy of the biosimilar. (uspharmacist.com)

The FDA's approval of an accelerated timeline for biosimilars signals a change in the industry and potential for severe drops in profits for pharmaceutical companies. (thebalance.com)
Less contentious were proposals to expand and revise FDA's "Purple Book" listings of patent and exclusivity information on new biologics to facilitate biosimilar development. (pharmexec.com)
The webcast "What You Must Know About FDA's New Biosimilars Guidance" being presented on April 12, 2012, from 11:00 AM - 12:00 PST will present further information on this topic. (groundzerous.com)
HERZUMA meets the FDA's rigorous standards as a biosimilar to the reference product for the approved indications based on a totality of evidence. (tevapharm.com)
The FDA's approval of Retacrit is based on a review of evidence that included extensive structural and functional characterisation, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Retacrit is biosimilar to Epogen/Procrit. (europeanpharmaceuticalreview.com)

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