• We did our trial with the trastuzumab biosimilar from Mylan in the first-line metastatic setting. (centerforbiosimilars.com)
  • In others, including the other published trial with the trastuzumab biosimilar from Celltrion, I chose the neoadjuvant setting with a different chemotherapy regimen than we commonly use. (centerforbiosimilars.com)
  • Mylan and Biocon, which have co-developed this proposed biosimilar, anticipate that this may be the first MAA for a Trastuzumab biosimilar accepted by the EMA for review. (prnewswire.com)
  • The PK study had demonstrated measured bioequivalence of Mylan's and Biocon's proposed Trastuzumab biosimilar relative to that of the reference drug. (prnewswire.com)
  • The Phase III study, HERITAGE, is a double-blind, randomized clinical trial designed to evaluate comparative efficacy and safety of the proposed trastuzumab biosimilar, MYL-1401O, versus branded trastuzumab. (prnewswire.com)
  • on December 29, 2017, the partnership announced that Brazil's National Sanitary Surveillance Agency (ANVISA) had approved their trastuzumab biosimilar. (centerforbiosimilars.com)
  • on December 29, 2017, the partnership announced that Brazil's National Sanitary Surveillance Agency (ANVISA) had approved their trastuzumab biosimilar for the treatment of overexpressing HER2-positive metastatic breast cancer, HER2-positive early breast cancer and HER2-positive advanced gastric cancer. (centerforbiosimilars.com)
  • In response to the prevailing threat of breast cancer in the Philippines, Pfizer has introduced a trastuzumab biosimilar to enable more Filipinos to have access to a more affordable treatment for HER2 positive breast cancer. (therainbowstar.net)
  • There are now 15 FDA-approved biosimilar products, up from nine in 2017. (managedhealthcareexecutive.com)
  • Notably, for Pfizer, sales of breast cancer drug Ibrance, which in April won FDA approval for men with HR+, HER2- metastatic breast cancer, spiked 31.7% last year from 2017 full-year figures. (pharmexec.com)
  • In late 2017, Spark won approval for Luxturna, the first-ever targeted gene therapy, which treats inherited retinal blindness. (pharmexec.com)
  • Production hurdles contributed to a slower rollout for Novartis's cell therapy Kymriah, the world's first CAR-T drug, which gained its first approval in August 2017. (pharmexec.com)
  • Scientific literature (1993 up to 30 June 2017) was reviewed to identify publications that contained primary data on single or multiple switching from reference biological medicines to biosimilars. (springer.com)
  • In 2017, the FDA beat the Scope's expectations for new approvals, with 55 given the green light instead of their projected 40. (outsourcing-pharma.com)
  • CT-P10 is the world's first monoclonal antibody (mAb) biosimilar approved by the European Commission (EC) for the treatment of oncology and was first launched in Europe in 2017. (tevapharm.com)
  • In February 2022, Viatris announced an agreement where it will contribute to Biocon Biologics its biosimilars portfolio and related commercial and operational capabilities in exchange for up to $3.335 billion, including a stake of at least 12.9% in Biocon Biologics. (wikipedia.org)
  • Breyna (Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol) received approval from the US FDA in March 2022 as the first generic version of Symbicort for the treatment of asthma and COPD. (wikipedia.org)
  • The rare cancer community also welcomes the introduction of Joint Clinical Assessments (JCAs) as part of the long-awaited approval of the EU Health Technology Assessment (HTA) Regulation , which came into force in January 2022 and which will see the introduction of JCAs from 2025. (esmo.org)
  • In 2022, the monoclonal antibodies product segment accounted for the largest share of the biosimilars market, mainly due to the low prices of biosimilar monoclonal antibodies compared to the reference drugs and increased adoption of labs in the treatment of cancer, autoimmune disorders, and osteoporosis. (rnrmarketresearch.com)
  • Oncology segment accounted for the largest share of the indication segment in 2022. (rnrmarketresearch.com)
  • In November 2022, Biocon Biologics completed the acquisition of Viatris' Global Biosimilars business. (ibef.org)
  • In May 2022, Biocon Biologics and Viatris Inc launched a biosimilar product Abevmy (bBevacizumab) in Canada for use in the treatment of cancer. (ibef.org)
  • In February 2022, Biocon got USFDA approval for its Posaconazole Delayed-Release tablets. (ibef.org)
  • Brochure CPHI Annual Report 2022: Psychedelic Approvals, VC Driven Contract Services Boom and Next Generation Manufacturing. (cphi-online.com)
  • Announced during a recently held Oncology Summit organized by Pfizer and held at Grand Hyatt Manila, Taguig Philippines that was attended by leading healthcare practitioners and Oncology experts, Pfizer's biosimilar Trastuzumab received the approval of the Philippines Food and Drug Administration (FDA) in March 2022 to bring this innovative treatment option to the Filipino patients. (therainbowstar.net)
  • Professor Justin Stebbing was a Professor of Cancer Medicine and Oncology at Imperial College, London (2009-2022), specialising in a range of malignancies, their treatment with immunotherapy (breast, GI and lung and clinical trials) and linking the laboratory to the clinic and vice versa and is now a visiting Professor there and a Professor of Biomedical Sciences at ARU Cambridge. (nature.com)
  • Attendees at an AMCP Nexus 2023 session received an overview of FDA approvals granted in 2023 as well as a preview of nononcology drugs to be released over the next 5 years. (drugtopics.com)
  • Tharaldson began her session with an overview of the market, including the growth of the biosimilar market in 2023, with the launch of 8 products referencing Humira (adalimumab) and the approval of the first tocilizumab and natalizumab biosimilars. (drugtopics.com)
  • Although 1 product has already been approved this year, donanemab is expected to receive FDA approval in December 2023. (drugtopics.com)
  • The global biosimilars market size is projected to reach USD 66.9 billion by 2028 from USD 29.4 billion in 2023, at a CAGR of 17.8% during the forecast period. (rnrmarketresearch.com)
  • In February 2023, Biocon raises US$ 129 million from Kotak Mahindra Group asset management to fund biosimilars deal. (ibef.org)
  • GlobalData has predicted that MSD's immuno-oncology blockbuster, Keytruda (pembrolizumab) is projected to be the best-selling drug by annual revenue in 2023, raking in $22.2bn by 2025. (pharmatimes.com)
  • The following products have been newly launched or received regulatory approvals since Viatris was established: Abevmy (Bevacizumab), a biosimilar, received European Commission approval in April 2021. (wikipedia.org)
  • Hulio (Adalimumab), a biosimilar, was launched in Japan and Canada in February 2021. (wikipedia.org)
  • Kixelle (Insulin aspart), a biosimilar, received European Commission approval in February 2021. (wikipedia.org)
  • Semglee (Insulin glargine-yfgn) received the first interchangeable biosimilar approval from the US FDA in July 2021. (wikipedia.org)
  • Branded and unbranded versions of the interchangeable biosimilars launched in November 2021. (wikipedia.org)
  • Basel, December 20, 2021 - Sandoz, a global leader in generic and biosimilar medicines, today announced the submission of its Biologics License Application (BLA) for a proposed biosimilar trastuzumab (150 mg, for intravenous use) developed by EirGenix, Inc. to the US Food and Drug Administration (FDA). (sandoz.com)
  • Biosimilar sales grew 51% to $2.3 billion in 2021, bolstered by the launches of three copycat cancer antibodies, namely Ruxience (rituximab), Zirabev (bevacizumab) and Trazimera (trastuzumab). (pharmaphorum.com)
  • This month, the Biosimilars Council took part in several important events, including a policy briefing with Rep. Kurt Schrader (D-OR) and the 2021 National Pharmacy Forum. (biosimilarscouncil.org)
  • Lastly, we are so grateful for the positive responses we've received for the 2021 Voices of Access Report , which details how biosimilars are changing lives for the better. (biosimilarscouncil.org)
  • Henlius has focused its efforts on becoming a fully-fledged biopharmaceutical company during 2021, moving away from its roots as a biosimilar drug company. (citeline.com)
  • Biocon and Sandoz will "develop, manufacture and commercialize multiple biosimilars in immunology and oncology for patients worldwide," the Indian biopharma company said in its release. (forbesindia.com)
  • It is expected that four key therapeutic areas that will drive growth in the years to come: immuno-oncology, immunology, rare diseases and vaccines. (outsourcing-pharma.com)
  • Celgene (CELG) keeps capitalizing on its strength in hematology and operational excellence to build global standards of care in the segments of Oncology and Inflammation & Immunology (I&I). Gilead, a prominent player in Hepatitis C therapy areas is looking to expand its learning in Liver disease for another high unmet need of Nonalcoholic Steatohepatitis (NASH), while its Oncolgy segment failed to make any major impact other than approved drug Zydelig. (reportsnreports.com)
  • The field of immuno-oncology is currently one of the most explosive fields in biotechnology. (reportsnreports.com)
  • Bristol-Myers's with more concentrated effort in Immuno-Oncology has gain the leadership with its Anti-PD-1 drug. (reportsnreports.com)
  • FDA approved 39 innovative drug therapies in 2012, the most new drug approvals in the U.S. since 1996. (managedhealthcareexecutive.com)
  • In 2012, the U.S. Food and Drug Administration (FDA) approved 39 innovative drug therapies-the most new drug approvals in the United States since 1996, when 53 new drugs were approved. (managedhealthcareexecutive.com)
  • In 2019, 21 of CDER's 48 novel drug approvals (44%) were approved to treat rare or 'orphan' diseases that affect 200,000 or fewer Americans," the report states. (ajmc.com)
  • Based on a variety of data, including new drug approvals and patent expirations, the authors project a 1-3 percent increase in drug expenditures across all settings, a 2-4 percent increase in expenditures for clinic-administered drugs, and a 1.5 percent increase in hospital drug expenditures for 2013. (stjude.org)
  • Additional biosimilars approvals are coming in 2019 and more applications will be submitted, as more brand-name biologics' patent protection periods expire. (managedhealthcareexecutive.com)
  • Lozano expects to see continued momentum in 2019, with more approvals and increasing acceptance of biosimilars as a viable treatment option. (managedhealthcareexecutive.com)
  • They found the economic advantage of biosimilars amounted to €274 per month for rituximab and €3,283‒€6,310 per month for trastuzumab, up to the time of treatment failure, which represented a 40% saving on the cost of the originator drugs ( Anticancer Res 2019, 39:3971‒73). (cancerworld.net)
  • A recently published analysis suggested that Europe as a whole could save between €0.91 bn and €2.27bn over the next five years by switching to trastuzumab biosimilars ( BioDrugs 2019, 33:423‒36). (cancerworld.net)
  • Increased use of almost 435% in Hungary and 515% in Slovakia was also reported by industry sources at the 2019 Biosimilars Commercialisation Summit . (cancerworld.net)
  • For instance, America will open up as a market for biosimilars of Trastuzumab, sold as Herceptin by Roche, the original drug maker, in 2019. (forbesindia.com)
  • As part of the license agreement signed in April 2019, EirGenix, Inc. is responsible for development and manufacturing and Sandoz will have the right to commercialize the medicine upon approval in all markets excluding China and Taiwan. (sandoz.com)
  • US healthcare costs are significantly higher than Europe's - the $11,000 spent per American in 2019 is more than double the amount per capita in France - with Europe's wider availability of cheaper generic drugs, or biosimilars, a contributing factor. (biosimilarscouncil.org)
  • The EC has granted marketing authorization for Stimufend (biosimilar, pegfilgrastim) in all approved indications of reference Neulasta. (pharmashots.com)
  • No. I think that you're going to use the biosimilar product across the different indications. (centerforbiosimilars.com)
  • Libbs is a pharmaceutical company that currently markets approximately 90 drug brands in 200 presentations for indications in gynecology, neurology, cardiology, oncology, and dermatology. (centerforbiosimilars.com)
  • It has received market approvals for over 20 oncology indications in the US, and is continuing to expand into new indications and markets globally. (pharmatimes.com)
  • Imbruvica has received FDA approval for multiple oncology indications and chronic graft-versus-host-disease. (pharmatimes.com)
  • Sandoz is seeking approval for the same indications as the reference medicine, based on a comprehensive package that includes analytical, preclinical and clinical data. (sandoz.com)
  • Celltrion, Inc. (KRX:068270) and Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee voted unanimously 16-0 to recommend approval of CT-P10, a proposed monoclonal antibody (mAb) biosimilar to Rituxan ®1 (rituximab) for the treatment of adult patients in three proposed indications. (tevapharm.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," said Woosung Kee, Chief Executive Officer of Celltrion. (tevapharm.com)
  • The market is classified into oncology, inflammatory & autoimmune disorders, chronic diseases, blood disorders, and other indications based on the indication. (insightaceanalytic.com)
  • 79% of respondents believe it is important that the label explicitly states that specific indications or conditions of use that are approved for the originator product are NOT approved for the biosimilar product. (gabionline.net)
  • The biosimilar Zarxio (filgrastim-sndz) was approved in the US for the five indications for which US-licensed Neupogen (filgrastim) was approved. (gabionline.net)
  • Cellitron is targeting several indications in its BLA application for the biosimilar. (dcatvci.org)
  • Sandoz has received final approval for its third biosimilar, filgrastim, paving the way for this important oncology medicine to be made available to patients across the European Union. (worldpharmanews.com)
  • Sandoz has been marketing its biosimilar for several years already, as Zarzio. (pharmaceuticalcommerce.com)
  • The FDA approval of Zarxio marks a significant milestone for the United States healthcare system and for patients who might suffer from neutropenia," said Carol Lynch, global head of biopharmaceuticals & oncology injectables at Sandoz, in a statement. (pharmaceuticalcommerce.com)
  • Biocon has struck a partnership with Sandoz, a unit of pharmaceuticals company Novartis AG, to jointly develop and market biosimilars, or generic versions of existing bio-drugs, in markets around the world, the Mumbai-listed biopharma company said in a press release on Thursday. (forbesindia.com)
  • The partnership with Sandoz, Novartis's generics unit, will help Biocon become an "end-to-end" operation - meaning from development to marketing of the biosimilars - at a much larger scale, billionaire Kiran Mazumdar-Shaw, Biocon's chairperson and managing director, said in the release. (forbesindia.com)
  • Sandoz has five biosimilars currently marketed worldwide, and more in its pipeline. (forbesindia.com)
  • Sandoz has been developing and providing oncology medicines for over 30 years. (sandoz.com)
  • The collaboration with EirGenix will enable Sandoz to build on its leading generic and biosimilar oncology portfolio to further expand patient access, while contributing to the sustainability of healthcare systems. (sandoz.com)
  • Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars. (sandoz.com)
  • Lyman also serves as chair of the American Society of Clinical Oncology (ASCO) Biosimilars Work Group. (managedhealthcareexecutive.com)
  • At the annual American Society of Clinical Oncology (ASCO) event held in June this year, 24 week data for the 'HERITAGE' study was presented. (prnewswire.com)
  • In June, the FDA approved Mylan and Biocon's application for Fulfila (pegfilgrastim-jmdb), the first biosimilar to Neulasta (pegfilgrastim) for reducing infection risk in some patients with non-myeloid cancers who are administered myelosuppressive chemotherapy. (managedhealthcareexecutive.com)
  • Last month, Mylan's MAA for the proposed biosimilar Pegfilgrastim was accepted for review by EMA. (prnewswire.com)
  • Expanded commercial footprint of key biosimilar, including Pegfilgrastim (Australia, Canada), Trastuzumab (the US, Australia, Canada) and Insulin Glargine (Australia) through its partner Mylan. (ibef.org)
  • Decreasing prices has in some cases brought increased access, says Adrian van den Hoven, Director General of Medicines for Europe, the organisation representing Europe's generic and biosimilar medicines industries. (cancerworld.net)
  • BENGALURU, India and HERTFORDSHIRE, England and PITTSBURGH , Aug. 25, 2016 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) announced today that the European Medicines Agency (EMA) has accepted for review Mylan's Marketing Authorization Application (MAA) for a proposed biosimilar Trastuzumab, which is used to treat certain HER2-positive breast and gastric cancers. (prnewswire.com)
  • To evaluate the possibility that switching from reference biologic medicines to biosimilars could lead to altered clinical outcomes, including enhanced immunogenicity, compromised safety, or diminished efficacy for patients, a systematic literature review was conducted of all switching studies between related biologics (including biosimilars). (springer.com)
  • The nature and intensity of safety signals reported after switching from reference medicines to biosimilars were the same as those already known from continued use of the reference medicines alone. (springer.com)
  • The experience with the reference medicine, in both pre-approval clinical trials and post-approval routine clinical practice of medicine, provides a baseline for the safety and efficacy expected for both reference medicines and their corresponding biosimilars. (springer.com)
  • Nonetheless, concerns have been raised that switching patients from reference medicines to biosimilars, or other structurally-related biologics, may lead to increased immunogenicity and consequential safety problems, or even a loss of efficacy. (springer.com)
  • Switches occur when patients receive medicines formally designated as biosimilars, but may also occur after manufacturing process changes have occurred, if the process changes lead to structural modifications or changes in the impurity profile of the biologic drug [ 5 ]. (springer.com)
  • this dynamic approach would allow patients with a high unmet need accelerated access to medicines that may improve their chances of survival but that do not yet have regulatory approval. (esmo.org)
  • The EC decision follows the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) positive opinion recommending approval of YESAFILI® in July. (biovoicenews.com)
  • In January, Polivy received conditional marketing approval from the European Medicines Agency, the pharmaceutical industry regulator for the European Union. (fool.com)
  • This practical tool offers a quick, evidence-based resource for hematology/oncology professionals to guide their medication-related decision-making and help ensure the administration of recent medicines for appropriate patients. (theoncologypharmacist.com)
  • ABP 215 is the most advanced of the four oncology biosimilar medicines on which Amgen and Allergan are collaborating. (dcatvci.org)
  • The companies formed their collaboration in December 2011 to develop and commercialize, on a worldwide basis, four oncology antibody biosimilar medicines. (dcatvci.org)
  • Biosimilars play an important role in the treatment of cancer, with the ability to both help increase patient access to essential medicines and provide value to the healthcare system by driving market competition that can lower the cost of care. (therainbowstar.net)
  • Emerging Markets said, "The entry of Pfizer's biosimilar medicines in the Philippine market is a very positive development. (therainbowstar.net)
  • Biotech and pharmaceutical companies pursue targeted and specialized therapies - more than 25% (45 new drugs approval vs. 44 in 2014) of drugs approved by FDA in 2015 are Personalized Medicines. (reportsnreports.com)
  • On 23 March 2015, the Alliance for Safe Biologic Medicines (ASBM), which represents patients and physicians, as well as originator biological and biosimilars companies in the US, released results of a survey, which showed that physicians 'support transparent, clear labels with data that enables prescribers to learn about and evaluate the medicines available to their patients' [1]. (gabionline.net)
  • ASBM Executive Director, Mr Michael Reilly stated that 'we believe this data provides FDA with clear guideposts for what is necessary to foster physician confidence in biosimilar medicines. (gabionline.net)
  • Excluding the COVID-19 products, Pfizer's underlying business grew 6%, a solid performance driven by gains for its biosimilar medicines, anti-clot drug Eliquis (apixaban) and Vyndaqel/Vyndamax (tafamidis meglumine) for transthyretin amyloid cardiomyopathy (ATTR-CM). (pharmaphorum.com)
  • The justices' 7-2 decision "ensures America's patients and taxpayers can continue to benefit from biosimilar access and competition in the marketplace," Rachel Schwartz, spokeswoman at the Association for Accessible Medicines, said in a statement. (biosimilarscouncil.org)
  • Europe's more liberal approach to biosimilar drug patents is continuing to give it an edge over the US in producing lower cost medicines - despite moves by Washington to ease market access for generic manufacturers. (biosimilarscouncil.org)
  • Alert CHMP Backs Once-Weekly GLP-1 Analog Semaglutide The nod from the European Medicines Agency's advisory panel follows approval by the US Food and Drug Administration. (medscape.com)
  • The Directorate pharmaceutical products by the Iraqi Ministry of Health regulates the following health products: medicines, from registration and approval to post-marketing, assess biotherapeutics, vaccines, blood and blood components, the main challenges faced and make recommendations herbal and traditional medicines, food supplements, to tackle the issues. (who.int)
  • The U.S. biosimilars market gained momentum over 2018, as more of the agents were submitted for FDA review and more regulatory approvals were granted, including additional immunosuppressive and cancer-treatment biosimilars. (managedhealthcareexecutive.com)
  • Sandoz's biosimilar adalimumab, Hyrimoz (adalimumab-adaz) injection was approved in October 2018, and Celltrion's Truxima (rituximab-abbs), the first biosimilar to be approved in the U.S. for non-Hodgkin lymphoma and the first approved biosimilar to Rituxan, was approved in November 2018. (managedhealthcareexecutive.com)
  • In May 2018, the FDA approved a biosimilar version of epoetin alfa (Epogen/Procrit), called Retacrit (epoetin alfa-epbx), for treatment of chemotherapy- and kidney disease-associated anemia, as well as for anemia resulting from zidovudine among HIV-positive patients. (managedhealthcareexecutive.com)
  • Of the four oncology biosimilars approved in 2018, three have already gone to market, says Rick Lozano, vice president of biosimilars and integrated business development, AmerisourceBergen. (managedhealthcareexecutive.com)
  • Congress and the FDA made it clear in 2018 that biosimilars "will be part of the solution" for controlling healthcare costs, Lozano says. (managedhealthcareexecutive.com)
  • The goal of this Guide is to offer oncologists, pharmacists, oncology nurses, and other healthcare stakeholders a comprehensive overview of new drugs approved by the US Food and Drug administration (FDA) in 2018 for the treatment of different types of cancer, including hematologic and oncologic malignancies. (theoncologypharmacist.com)
  • On this episode of Not So Different, the FDA's Sarah Yim, MD, discusses how the FDA is working to improve public trust in ophthalmology biosimilars and interchangeable products as part of a 3-part multimedia interview series. (centerforbiosimilars.com)
  • Herceptin remains Roche's top-selling medicine, but its patent has expired, and according to a report in Reuters , the drug's sales dropped 16% in Europe last year, and potential US competition looms this year from biosimilars from Celltrion and Teva, Pfizer, and Mylan. (pharmexec.com)
  • Biocon and Mylan are exclusive partners on a broad portfolio of biosimilars and insulin analogs. (prnewswire.com)
  • The proposed biosimilar Trastuzumab is one of the six biologic products co-developed by Mylan and Biocon for the global marketplace. (prnewswire.com)
  • Mylan has exclusive commercialization rights for the proposed biosimilar Trastuzumab in the U.S., Canada , Japan , Australia , New Zealand , the European Union and European Free Trade Association countries. (prnewswire.com)
  • The ANVISA approval was granted through Mylan and Biocon's Brazilian partner, Libbs Farmaceutica. (centerforbiosimilars.com)
  • Should the Mylan and Biocon product gain EMA clearance, the drug will eventually compete with Celltrion's recently EMA-approved biosimilar trastuzumab, Herzuma, as well as Samsung Bioepis' EMA-approved product, Ontruzant. (centerforbiosimilars.com)
  • The partnership will extend Biocon's efforts to produce biosimilars, get approvals in America and Europe, beyond the one it has with Dutch company Mylan NV, Biocon said in its release. (forbesindia.com)
  • Mylan is marketing Biocon's biosimilar of Trastuzumab, a breast cancer drug, which recently became the first such bio-generic to be approved in the US. (forbesindia.com)
  • Specialists in dermatology, endocrinology, oncology, nephrology, neurology and rheumatology were included in the research, which was carried out via a web-based survey. (gabionline.net)
  • Amjevita is a biosimilar of Humira (adalimumab), AbbVie's anti tumor necrosis factor (TNF) monoclonal antibody that is indicated in the US for treating rheumatoid arthrititis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult and pediatric Chrohn's disease, and ulcerative colitis. (dcatvci.org)
  • Monoclonal antibody biosimilars play a vital role in treating various chronic and autoimmune diseases. (insightaceanalytic.com)
  • Headquartered in Incheon, Korea, Celltrion is a leading biopharmaceutical company, specializing in research, development and manufacturing of biosimilar and innovative drugs. (tevapharm.com)
  • The US Food and Drug Administration (FDA)'s Arthritis Advisory Committee will hold a public meting on March 17, 2015, to discuss the biologics license application (BLA) of Celltrion Inc. an Incheon, South Korea-based developer of biosimilars, for a proposed biosimilar to Janssen Biotech Inc.'s Remicad (infliximab). (dcatvci.org)
  • In August 2014, Celltrion filed the BLA for its biosimilar, Remsima through the US FDA's biosimilar regulatory approval pathway under the Biologics Price Competition and Innovation Act of 2009 (BPCIA). (dcatvci.org)
  • In filing for US FDA approval, Celltrion said it consulted with the US FDA and conducted additional clinical trials (starting on October 2013 and lasting six months) to determine the bioequivalency of the originator products with Remsima. (dcatvci.org)
  • Celltrion obtained approval for its biosimilar infliximab product, which uses the registered brand name of Remsima, from over 50 countries worldwide, including in Europe, Canada, and Japan. (dcatvci.org)
  • Both companies are to share responsibility for end-to-end development, manufacturing and global regulatory approvals. (forbesindia.com)
  • Factors such as regulatory approvals, favorable reimbursement policies, rising demand for cost effective biosimilars is driving the market growth. (rnrmarketresearch.com)
  • Scope's report finds biologics likely to be protected from severe biosimilar erosion but sees warning signs for the generics industry. (outsourcing-pharma.com)
  • 2. GaBI Online - Generics and Biosimilars Initiative. (gabionline.net)
  • Biocon has successfully launched its insulin glargine in Japan, biosimilars of Trastuzumab and Bevacizumab in India and rh- Insulin, Insulin Glargine and biosimilar Trastuzumab in few emerging markets. (forbesindia.com)
  • In some countries savings are also being invested in providing access to novel, more expensive treatments, which may partly explain why oncologists, in the experience of van den Hoven, have been generally more open to switching than were clinicians working in the more chronic diseases, such as rheumatoid arthritis, where biosimilars were introduced earlier. (cancerworld.net)
  • The acceptance and the willingness of clinician to use biosimilars has been much faster in the area of oncology, for first-line and second-line treatments," he says. (cancerworld.net)
  • Rilpivirine and islatravir are 2 HIV treatments pending FDA approval. (drugtopics.com)
  • However, it is the relatively small population within each rare cancer subgroup that makes the development and regulatory approval of new treatments so challenging. (esmo.org)
  • The EU regulation on orphan medicinal products has been instrumental in achieving regulatory approval for rare cancer treatments. (esmo.org)
  • Included in the report were numerous approvals for treatments targeted at combatting rare diseases like cystic fibrosis, tenosynovial giant cell tumor, and sickle cell disease. (ajmc.com)
  • In addition to approvals for rare diseases, CDER announced in its report the approval of treatments for certain cancers, blood disorders, autoimmune conditions, and heart, lung, circulatory, and endocrine diseases. (ajmc.com)
  • Three of the company's cancer treatments -- Rituxan, Avastin, and Herceptin -- now face competition from biosimilars, and their sales have declined as a result. (fool.com)
  • Global Biosimilar Monoclonal Antibodies market growth is attributed to numerous factors such as biosimilar monoclonal antibodies market include the increasing patent expiries of mAbs, innovation of advanced mAbs, the growing number of biosimilars for oncology treatments, rising demand for lower-priced, cost-efficient biosimilar monoclonal antibodies, growing chronic and autoimmune diseases like cancer, rheumatoid arthritis, diabetes, and the rising older population. (insightaceanalytic.com)
  • Among all, The oncology segment is predictable to dominate the market in the coming years due to the surge in biosimilar mAbs approvals for cancer treatments. (insightaceanalytic.com)
  • Biosimilar competition has the potential to provide greater access to important treatments for America's patients and cost savings for the nation's health care system of as much as $130 billion by 2025. (biosimilarscouncil.org)
  • If signed into law, this bill will accelerate patient access to new lower-cost biosimilar treatments by providing a temporary payment increase to clinicians that prescribe them. (biosimilarscouncil.org)
  • His clinical trials have focused on novel mechanisms of action and also biosimilars, democratising expensive treatments. (nature.com)
  • Boehringer Ingelheim Pharmaceuticals announced that the FDA has approved Cyltezo (adalimumab-adbm), a biosimilar to Humira (adalimumab), according to a press release. (pharmacytimes.com)
  • Amgen's Humira biosimilar, Amjevita (adalimumab-atto), is engaged in a similar lawsuit. (pharmacytimes.com)
  • The biggest saving (£110m ‒ €127m) came from switching to biosimilars of Humira (adalimumab) ‒ a medicine used to treat inflammatory conditions. (cancerworld.net)
  • Humira is forecast to fall to sixth place by 2025, a decline expected due to anticipated biosimilar competition in the EU and US. (pharmatimes.com)
  • Market leading drugs, such as AbbVie's Humira (adalimumab) ​ and selected therapies within Roche's portfolio ​, will begin to face biosimilar competition this year and next. (outsourcing-pharma.com)
  • The FDA will take the Committee's recommendation into consideration before taking action on the Biologics License Application (BLA) for the proposed Rituxan ® biosimilar. (tevapharm.com)
  • Celltrion's CT-P10, a proposed biosimilar to Biogen and Genentech USA, Inc.'s Rituxan ® , is currently approved in 47 countries across the globe. (tevapharm.com)
  • Pfizer's oncology portfolio, along with Eliquis and the company's biosimilars, are reportedly expected to drive near-term earnings growth for the pharma giant. (pharmexec.com)
  • Gennova is transforming healthcare by creating efficient and effective solutions for manufacturing and successfully commercializing bio-therapeutics across cardiovascular, neurology, nephrology, and oncology segments. (siliconvillage.net)
  • Biocon Biologics has been granted marketing authorization in the European Union (EU) for YESAFILI®, a biosimilar of Aflibercept by the European Commission (EC). (biovoicenews.com)
  • We're just seeing the cusp or initial wave of these cancer-treating biosimilars," says Gary H. Lyman, MD, MPH, FASCO, FRCP, professor of medical oncology at the University of Washington School of Medicine, in Seattle. (managedhealthcareexecutive.com)
  • The results of the 48 week extension data of the 'HERITAGE' study are expected to be presented at the upcoming European Society for Medical Oncology Congress (ESMO) in October. (prnewswire.com)
  • Amgen and Allergan have submitted a biologics license application to the US Food and Drug Administration (FDA) for ABP 215, a biosimilar candidate to Avastin (bevacizumab), Roche's anti-cancer biologic. (dcatvci.org)
  • Biogen says it is the first drugmaker in the US to get FDA approval for a biosimilar of Roche's $3 billion blockbuster product Actemra. (pharmaphorum.com)
  • Iceland-based Alvotech announced the approval of its ustekinumab biosimilar referencing Stelara in Japan for autoimmune conditions. (centerforbiosimilars.com)
  • Celltrion's strategic focus is to develop and manufacture biosimilar monoclonal antibodies and novel drugs for various therapeutic areas, including oncology and autoimmune diseases. (dcatvci.org)
  • However, in the interim, it will be known as figrastim-sndz, which FDA says is a "placeholder nonproprietary name" which "should not be viewed as reflective of the agency's decision on a comprehensive naming policy for biosimilar and other biological products. (pharmaceuticalcommerce.com)
  • The promise of cheaper biological drugs is now coming to fruition in oncology. (cancerworld.net)
  • Biosimilars are biological drugs, and they are large, complex biological molecules produced from living organisms that are often difficult to characterize and therefore difficult to copy. (insightaceanalytic.com)
  • The agency has stated that this decision should not be viewed as reflective of the agency's decision on a comprehensive naming policy for biosimilar and other biological products. (gabionline.net)
  • The World Health Organization is considering the use of a biological qualifier (possibly a four-letter code) to distinguish biosimilars [5]. (gabionline.net)
  • WHO investigates use of a biological qualifier for biosimilars [www.gabionline.net]. (gabionline.net)
  • FDA is hoping to issue guidance on this controversial aspect of biosimilar commercialization in the near future. (pharmaceuticalcommerce.com)
  • The APAC market is expected to be the fastest-growing regional segment during the forecast period due to the presence of numerous emerging players, less-stringent government regulations, and increasing cooperation among leading and regional players for development, manufacturing and commercialization of biosimilars. (rnrmarketresearch.com)
  • In another recent analysis, looking at the economic impact of switching to trastuzumab and rituximab biosimilars, an Italian team evaluated five phase II trials including 2,362 patients being treated for advanced breast cancer or follicular lymphoma. (cancerworld.net)
  • With more than a decade of global inmarket experience, a portfolio of nine approved biosimilar products across different diseases in the U.S. and the broadest biosimilar portfolio for oncology supportive care, Pfizer is proud to be a global leader in biosimilars and at the forefront of this vital healthcare segment. (therainbowstar.net)
  • Pfizer uses robust protocols to ensure the same high-quality standards are maintained in its biosimilars as its biologics throughout every stage of the manufacturing process. (therainbowstar.net)
  • The regulatory submission for proposed biosimilar Trastuzumab in Europe takes us a step closer towards enabling affordable access to this critical biologic therapy for the treatment of HER2-positive breast cancer. (prnewswire.com)
  • In a statement, Mylan's CEO, Heather Bresch, highlighted the fact that the biosimilar could bring about greater patient access to biologic treatment for cancer: "The number of women diagnosed with breast cancer in Brazil is increasing. (centerforbiosimilars.com)
  • The distinguished speakers were hopeful that with the launch of the new biosimilar, the treatment of breast cancer can become more affordable. (therainbowstar.net)
  • Alert Europe Says No to Neratinib for Breast Cancer The European committee recommended against approval of neratinib (Nerlynx) for breast cancer, even though the drug has been approved in the United States. (medscape.com)
  • Henlius says it can now pursue a "differentiated strategy" for its HLX01 rituximab biosimilar in China, after winning approval for a key rheumatoid arthritis indication from the NMPA. (citeline.com)
  • Alert EMA Committee Backs Remicade Biosimilar Zessly The committee favors marketing the infliximab biosimilar product Zessly for treatment of rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis. (medscape.com)
  • While use of each biologic must be assessed individually, these results provide reassurance to healthcare professionals and the public that the risk of immunogenicity-related safety concerns or diminished efficacy is unchanged after switching from a reference biologic to a biosimilar medicine. (springer.com)
  • Our biosimilar products have received regulatory approval based on the overall assessment of similarity to an existing biologic medicine. (therainbowstar.net)
  • INCHEON, Korea--( BUSINESS WIRE )-- Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved a 420 mg multi-dose vial of ONTRUZANT ® (trastuzumab-dttb), a biosimilar referencing HERCEPTIN ® i (trastuzumab). (biospace.com)
  • Approval of China's first rituximab biosimilar under new pathway gives developers much-needed boost and an opening to the international market for made-in-China biosimilars helped by favorable regulatory policy changes at home. (citeline.com)
  • Biosimilars do not have to be declared interchangeable with their reference brand-name biologics to be prescribed, but an interchangeability determination would allow substitution by pharmacists. (managedhealthcareexecutive.com)
  • From the 39 novel drugs, the United States was the forerunner in terms of giving approval to 75% of these drug therapies before they were made available in other countries," says Abimbola Farinde, PharmD, clinical staff pharmacist at Clear Lake Regional Medical Center in Webster, Texas. (managedhealthcareexecutive.com)
  • It is the firm belief of FDA that Americans should be able to have access to drug therapies that are both safe and effective, which also could have provided the momentum that led to the approval of these novel drugs, in particular for difficult-to-treat disease states. (managedhealthcareexecutive.com)
  • Biosimilars for supportive therapies used in oncology have been available in Europe for over a decade. (cancerworld.net)
  • At least a further eight oncology biologics will come off patent in the next four years, bringing cheaper prices, with the hope of investing the savings in treating more patients and increasing access to other therapies. (cancerworld.net)
  • Cancer therapies in particular stand out as costly drugs for hospitals and clinics, and the paper summarizes the high costs for new oncology agents that came on the market in 2012 and the top 20 antineoplastic drug expenditures in clinics in 2011 and 2012. (stjude.org)
  • We have reached a new threshold where a course of treatment for some new cancer therapies can cost more than $100,000, which illustrates the growing challenge oncology drug costs present to hospitals and clinics," he said. (stjude.org)
  • The development of biosimilars is of great importance in the field of oncology, and has the potential to increase accessibility to therapies for patients. (tevapharm.com)
  • On the basis of technology, biosimilar antibody products are the fastest growing segment. (sbwire.com)
  • Under the agreement, Amgen will assume primary responsibility for developing, manufacturing, and initially commercializing the oncology antibody products. (dcatvci.org)
  • FDA does not issue approval announcements for every approval or drug label update that occurs in oncology and hematology. (blogspot.com)
  • ONTRUZANT ® will be marketed and distributed in the United States (US) by Merck (known as MSD outside the US and Canada), which announced on February 5, 2020, that it intends to spin-off products from its biosimilars businesses, including ONTRUZANT ® , into a new, independent, publicly-traded company. (biospace.com)
  • Looking ahead, policy makers are seriously exploring the interchangeability between biosimilars and their reference products as part of the blueprint for lowering drug prices. (managedhealthcareexecutive.com)
  • That alignment is starting to better pave the way for more products to come to market, as evidenced by this year's uptick in approvals. (managedhealthcareexecutive.com)
  • Antineoplastic agents were the top medication expenditures in nonfederal hospitals in 2012, accounting for 15.1 percent of all hospital drug expenditures in 2012, while oncology products accounted for 32.2 percent of drug expenditures in clinics during the first nine months of 2012. (stjude.org)
  • Camcevi® 42mg is an important addition to of the rapidly expanding Accord Biopharma oncology portfolio and provides clinicians an important option for the treatment of advanced prostate cancer," Said Chrys Kokino, U.S. President Accord BioPharma specialty products. (harbingervc.com)
  • Please refer to Drugs@FDA for the latest approvals and prescribing information for specific products. (blogspot.com)
  • Biosimilar introduction facilitates lower prices of brand name biologics (reference products) and biosimilars in every class, so even patients who decide to stay on brand-name biologics benefit. (biosimilarscouncil.org)
  • Alert EU Panel Likes Biosimilar Bevacizumab, Other Cancer Agents The Committee for Medicinal Products for Human Use has issued a new list of recommendations and rejections for oncology products. (medscape.com)
  • GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Oncolytic Virus to Target CD46 and SLC5A5 for Oncology LoA Report. (pharmaceutical-technology.com)
  • With the review of the new therapeutic drug classes that have received FDA approval, Dr. Farinde says that she is looking forward to the release of 10 drugs that will be indicated to treat various forms of cancer including late-stage colorectal cancer, prostate cancer and myelofibrosis. (managedhealthcareexecutive.com)
  • The Approval in the US, in December, marked a major milestone for Biocon, and for the Indian pharma industry as well, which grew to become a large sector on the back of generic versions of chemical drugs, over the last 25 years. (forbesindia.com)
  • Chemical drugs are easier to make in factories, and to get approvals for. (forbesindia.com)
  • This week, the FDA's Center for Drug Evaluation and Research (CDER) released its annual report, Advancing Health Through Innovation: New Drug Therapy Approvals, outlining new drugs approved or marketed in America for the first time. (ajmc.com)
  • However, subsequent trials must be conducted on these drugs to support full approval. (ajmc.com)
  • Hoffman added that several other developments will influence prescription drug expenditures in coming years, including the Food and Drug Administration's implementation of an approval process for biosimilars and other actions that facilitate the introduction of generic drugs into the medication pipeline. (stjude.org)
  • Underpinning the agency's confidence in the pharma market is it the number of US Food and Drug Administration (FDA) approvals for new drugs. (outsourcing-pharma.com)
  • However, the report notes that this could be mitigated by a slow uptake of biosimilars and the possibility that such rival treatment would not be able to 'crowd-out' the originator drugs. (outsourcing-pharma.com)
  • Despite Amjevita's approval in September 2016, the drug has yet to be launched in the US market. (pharmacytimes.com)
  • Amgen has a total of nine biosimilars in its portfolio, one of which, Amjevita (adalimumab-atto), was approved by the FDA in September 2016 . (dcatvci.org)
  • Biologics License Application (BLA) is supported by analytical, pre-clinical and clinical data, proposed biosimilar trastuzumab developed by EirGenix, Inc. (sandoz.com)
  • As the global leader in biosimilars, we are honored to be the first company to successfully work with FDA to navigate the US biosimilar pathway and we look forward to making this high-quality biosimilar available to patients in the US. (pharmaceuticalcommerce.com)
  • Cyltezo is the first biosimilar from Boehringer Ingelheim to be approved by the FDA and marks an important step towards our goal of providing new and more affordable treatment options to healthcare providers and patients," said Ivan Blanarik, senior vice president and head of Therapeutic Area Biosimilars at Boehringer Ingelheim. (pharmacytimes.com)
  • The FDA is also preparing new guidelines on biosimilar product labels, which Lozano hopes will create a "more level playing field" between biosimilars and biologics by helping to reassure healthcare providers that biosimilars are safe and effective. (managedhealthcareexecutive.com)
  • Padcev (anfortumab vedotin-ejfv) injection was approved under the FDA's accelerated approval program as an option for patients with refractory bladder cancer. (ajmc.com)
  • Food and Drug Administration granted accelerated approval to rucaparib (RUBRACA, Clovis Oncology, Inc.) for patients with deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. (blogspot.com)
  • Food and Drug Administration granted accelerated approval to capmatinib (TABRECTA, Novartis) for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test. (blogspot.com)
  • Alert Rucaparib for Ovarian Cancer OK'd for Approval in Europe The PARP inhibitor rucaparib has been recommended for approval in Europe for use in relapsed or progressive BRCA-mutated ovarian cancer. (medscape.com)
  • Alert EU Says Yes to Mylotarg for AML, No to Adjuvant Sunitinib Gemtuzumab ozogamicin (Mylotarg) has been recommended for approval in Europe for use in acute myeloid leukemia, but adjuvant sunitinib after kidney cancer surgery was turned down. (medscape.com)
  • He said Pfizer's biosimilar brand is significantly lower in price than the equivalent reference medication in the market. (therainbowstar.net)
  • The European Commission approved the first aflibercept biosimilar, which will be used to treat patients with age-related macular degeneration and diabetic macular edema. (centerforbiosimilars.com)
  • Oncolytic Virus to Target CD46 and SLC5A5 for Oncology is under clinical development by Vyriad and currently in Phase I for Atypical Teratoid Rhabdoid Tumor. (pharmaceutical-technology.com)
  • Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. (pharmaceutical-technology.com)
  • GlobalData's Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). (pharmaceutical-technology.com)
  • The biosimilar approval was based on numerous findings from analytical, pharmacological, non-clinical and clinical development trials that showed Cyltezo is highly-similar to the reference product. (pharmacytimes.com)
  • Expect oncology to be a fundamental driver for a lot of deal-making activity, as it encompasses over one-third of both pipeline assets and clinical trials. (pharmamanufacturing.com)
  • Biosimilar development from Large ad Biotech companies are progressing well with many reaching to regulatory space and in lates stage of clinical trials. (reportsnreports.com)
  • 83% of respondents thought that it was important that the biosimilar label includes the clinical data, if any, submitted to the Food and Drug Administration (FDA) by the biosimilar sponsor to demonstrate that it is highly similar to the reference product. (gabionline.net)
  • During the COVID-19 pandemic, papers published by Justin described use of artificial intelligence to find a new treatment, leading to mechanistic and clinical studies for baricitinib and then its FDA approval. (nature.com)
  • Below is a guide to navigating a dozen endpoints used in oncology clinical trials. (medscape.com)
  • The approval allows pharmacists to substitute Semglee for the reference product, Lantus. (wikipedia.org)
  • You have to think about the amount of money and work that goes into getting to that place, where you get approval and it goes onto market, and also the competition, which, of course, the originator product doesn't have. (centerforbiosimilars.com)
  • We look forward to continuing to work to bring this product to patients upon approval. (prnewswire.com)
  • The approval of Zedora…is an important step in our efforts to increase access to this critical product for patients with certain breast and gastric cancers and reduce the overall financial burden for health systems around the world. (centerforbiosimilars.com)
  • An FDA workshop featuring regulators from around the world provided the regulatory perspective on how each government determines whether a biosimilar is clinically equivalent to their reference product, highlighting the science behind their development guidelines. (centerforbiosimilars.com)
  • We are very pleased to receive the European Commission's approval of our YESAFILI® biosimilar as we continue to expand our biosimilar offerings across the globe, building on our oncology and diabetes product portfolio. (biovoicenews.com)
  • Emerging as an effective treatment for a range of cancers, Keytruda has developed into Merck & Co's biggest product since its Food and Drug Administration (FDA) approval in 2015. (pharmatimes.com)
  • The Biosimilar Monoclonal Antibodies Market is segmented based on product, indication, and region. (insightaceanalytic.com)
  • 90% of respondents thought that it was important that a product label for a biosimilar clearly indicates that it is a biosimilar. (gabionline.net)
  • 82% of respondents believe it is important that the biosimilar label includes the analytical data developed by the biosimilar sponsor to demonstrate its analytical similarity to the reference product. (gabionline.net)
  • He added that 'the survey was conducted prior to the first biosimilar approval and is more consistent with the draft guidance released in 2012 than the label of the first biosimilar product. (gabionline.net)
  • 5 biosimilars, including one pioneering - a 'first-in-the-world' product. (siliconvillage.net)
  • Dolutegravir received US FDA approval in December 2020 to treat children with HIV/AIDS in low to middle income countries. (wikipedia.org)
  • North America region dominated this market in 2020 and is expected to continue its trend over the forecast period on account of the favourable reimbursement policies, increasing patent expiration, and the growing rate of biosimilar mAbs approvals. (insightaceanalytic.com)
  • Following the formation of Viatris, the company became a member of the Biosimilars Forum, a trade organization that advocates for greater biosimilar usage. (wikipedia.org)