Biosimilar Pharmaceuticals

Therapeutic Equivalency

Drug Approval

Biological Products

Drug Industry

Legislation, Drug

Pharmaceutical Preparations

Patents as Topic

Hematologic Agents

Guidelines as Topic

European Union

Biosimilar

Amneal Pharmaceuticals

Intas Pharmaceuticals

Association for Accessible Medicines

List of Johnson & Johnson products and services

Róbert Wessman

Pharmaceutical industry in India

Patent cliff

Adalimumab

Fine chemical

Pharmaceutical Care Management Association

Biopharmaceutical

Celltrion

Generic drug

Proprietary drug

Etanercept

Panacea Biotec

Me-too drug

Hetero Drugs

AbbVie

SemBioSys Genetics

Lonza Group

Biocon

Leena Tewari

British Generic Manufacturers Association

Arven Pharmaceuticals

Filgrastim

Cefuroxime

Sagent Pharmaceuticals

Teva Pharmaceuticals

Kiran Mazumdar-Shaw

Structured Product Labeling

Aurobindo Pharma

Alvogen

List of largest biomedical companies by revenue

David Charles (physician)

Hospira

Granulocyte colony-stimulating factor

Non-biological complex drugs

Hugo Sigman

Drug Price Competition and Patent Term Restoration Act

Prescription drug prices in the United States

Gedeon Richter (company)

Reading Scientific Services

Bevacizumab

Russell J. Howard

Avesthagen

Quality by design

DRI Capital

Evergreening

Kyowa Kirin

Harness, Dickey & Pierce

Actavis

Follow-on Biolog1

• Pharmaceutical companies in India have had a hold on the biotechnology sector for many years, and they're not about to let the follow-on biologics market pass them by. (pharmtech.com)

Monoclonal antibodies3

• GMP lot or batch release testing services for biologic drug substances or drug products are important to ensure the quality control of proteins, monoclonal antibodies (mAbs) or biosimilars. (intertek.com)
• Intertek's release tests are applied to biosimilars , protein therapeutics , monoclonal antibodies , oligonucleotides and other biotechnology products. (intertek.com)
• 8. Overcoming Barriers to the Market Access of Biosimilars in the European Union: The Case of Biosimilar Monoclonal Antibodies. (nih.gov)

Biologics and biosimilars2

• Welcome to the era of biologics and biosimilars. (mcgill.ca)
• 11. The growing role of biologics and biosimilars in the United States: Perspectives from the APhA Biologics and Biosimilars Stakeholder Conference. (nih.gov)

Multiple biosimilars1

• Sandoz and Just - Evotec Biologics are partnering to develop and manufacture multiple biosimilars with an option for expansion. (drugstorenews.com)

Filgrastim2

• On June 12, the court ruled - in the combined patent cases of Sandoz v Amgen and Amgen v Sandoz - that Sandoz had the right to market a biosimilar version of Amgen's Neupogen (filgrastim)‎ before receiving FDA approval. (medscape.com)
• Litigation began after Sandoz announced its intention to seek a license from the FDA to market a filgrastim biosimilar. (medscape.com)

Originator10

• Based on extrapolation of similar clinical outcomes in rheumatoid arthritis to the originator infliximab (IFX) in randomized clinical trials, the first biosimilar antibody CT-P13 was approved for the treatment of psoriasis. (nih.gov)
• Ideally, drug companies and payers would pass along the 20% to 30% they save when they acquire the biosimilar instead of the originator. (medscape.com)
• Comparative effectiveness of pegfilgrastim biosimilars vs originator for prevention of febrile neutropenia: A retrospective cohort study. (bvsalud.org)
• Real-world evidence on the comparative effectiveness of pegfilgrastim biosimilars compared with the originator product is limited. (bvsalud.org)
• To compare the risk of febrile neutropenia (FN) among users of pegfilgrastim biosimilars (pegfilgrastim-jmdb and pegfilgrastim-cbqv) and the originator product. (bvsalud.org)
• A retrospective cohort study was conducted using 2019 IBM MarketScan databases to assess comparative effectiveness of pegfilgrastim originator and biosimilars for prevention of FN among patients receiving myelosuppressive chemotherapy . (bvsalud.org)
• We further selected patients who used pegfilgrastim originator and biosimilars within 3 days of chemotherapy completion. (bvsalud.org)
• After 11 propensity score matching, we used equivalence (with a margin of 6%) hypothesis tests to compare FN-related hospitalization risk in the first cycle and across all cycles between biosimilars and originator users. (bvsalud.org)
• In this real-world study of patients with cancer receiving myelosuppressive chemotherapy , there was no difference in FN risk between patients receiving pegfilgrastim originator and biosimilars in the first cycle and across all cycles. (bvsalud.org)
• Biosimilars are copies of biological products introduced into the market to offer clinical efficacy like the originator or reference product at lower prices. (who.int)

Biologic4

• In fact, biosimilar manufacturers can now start the clock on the 6-month exclusivity window that is afforded the maker of the original biologic as much as 180 days before the FDA approval meeting. (medscape.com)
• The switch from a biologic to a biosimilar is unlike the switch from a brand-name small-molecule drug to a generic formulation, where patients often directly benefit from the lower cost. (medscape.com)
• Biosimilars is an FDA classification for biological products "highly similar" to an approved biologic already being used to treat patients. (eagleus.com)
• Pharmaceutical drugs and biologics logistics is the logistics of pharmaceutical and biologic drugs from the manufacturer to the end-user. (thebusinessresearchcompany.com)

20172

• MADRID - A unanimous Supreme Court decision on biosimilars, which industry insiders anticipate will lower drug costs, probably won't lead to cheaper prices for patients or physicians wrangling with nonmedical switching, delegates heard at the recent European League Against Rheumatism (EULAR) Congress 2017. (medscape.com)
• The acquisition of FMC s Health & Nutrition business in November 2017 alleviated the company s position in the global pharmaceutical excipients market bringing an extensive range of products under one roof. (marketsandmarkets.com)

20202

• It is estimated that the global biosimilar market may reach $20-$26 billion by 2020 1 . (eagleus.com)
• The global pharmaceutical drugs and biologics logistics market reached a value of nearly $90,300.0 million in 2020, having increased at a compound annual growth rate (CAGR) of 4.1% since 2015. (thebusinessresearchcompany.com)

Medicines10

• The European Medicines Agency (EMA) provided the regulatory approval framework for biosimilars, approving the first biosimilar in 2006. (eagleus.com)
• Dr. Lutz Hilbrich, Chief Executive Officer of MiGenTra GmbH, said: 'This agreement with Bioventure will allow MiGenTra to provide patients across Africa and the Middle East with a unique set of high quality and affordable biological medicines by combining in-house developed biosimilars with Alvotech's highly complementary candidates. (migentra.com)
• Alvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. (migentra.com)
• WASHINGTON - Gov. Dannel P. Malloy and other elected officials lobbied the Obama administration for a provision in the Trans-Pacific Partnership trade pact that would protect pharmaceutical companies making some of the most cutting-edge and expensive drugs against competitors who want to make cheaper, generic versions of those medicines. (ctmirror.org)
• To curb medicine costs, use of comparable and often less expensive biosimilar medicines is fostered. (fip.org)
• 1. Informing Patients about Biosimilar Medicines: The Role of European Patient Associations. (nih.gov)
• 5. Perceptions About Biosimilar Medicines Among Belgian Patients in the Ambulatory Care. (nih.gov)
• 14. Regulation of biosimilar medicines and current perspectives on interchangeability and policy. (nih.gov)
• 16. Biosimilar medicines. (nih.gov)
• 20. Assessing awareness and attitudes of healthcare professionals on the use of biosimilar medicines: A survey of physicians and pharmacists in Ireland. (nih.gov)

20162

• There have been 22 different biosimilar products approved by the European Union as of March 2016. (eagleus.com)
• The first biosimilar was approved in the U.S. in March 2015, with four biosimilars approved as of October 2016. (eagleus.com)

Sandoz3

• In handing a victory to Sandoz, a generic pharmaceutical company, the Supreme Court judges reversed a Federal Circuit Court ruling that had favored Amgen. (medscape.com)
• The US District Court of New Jersey has decided in favour of Amgen 's Enbrel (etanercept-szzs), in a patent conflict against its biosimilar Erelzi (etanercept), produced by Sandoz , a division of Novartis. (europeanpharmaceuticalreview.com)
• Sandoz has announced that it will appeal the court's decision although the injunction will keep the biosimilar off the market. (europeanpharmaceuticalreview.com)

Biobetters4

• Nevertheless, under the current regime, we risk the possibility that companies will focus on developing so-called biodifferents and biobetters (new drugs designed to mimic an existing biological drug), completely forgoing the opportunity to develop biosimilars. (ssrn.com)
• It is doubtful that biobetters and biosimilars will have the same price-lowering effects as generics. (ssrn.com)
• While large pharmaceutical companies around the world invest heavily in biosimilars, Eagle's and Arsia's combined know-how and execution capabilities will allow us to improve upon those formulations to create biobetters, which we believe will be key to product differentiation, pricing power and larger market share. (eagleus.com)
• We plan to partner with key biosimilar companies to help alter their existing pipelines into biobetters. (eagleus.com)

Economics1

• This will affect "the economics of the pharmaceutical industry. (medscape.com)

20192

• The Global Conference on Pharmacy and Pharmaceutical Science (GPPS 2019) will be held during June 26-27, 2019 at Bali, Indonesia. (frontiersin.org)
• Pharmacy and Pharmaceutical Science 2019 is a global platform for. (frontiersin.org)

Switching may affe1

• Patient perceptions towards biosimilars and their use in switching may affect treatment outcomes and costs but the literature on the subject is. (fip.org)

Antibody1

• One movement that's really coming on is called biosimilars, which is where companies can produce an antibody that's not exactly like the one that is being marketed. (medlineplus.gov)

Market15

• I find that biosimilar entrance into the market is related to large decreases in utilization for biologics and that biosimilars in the US tend to penetrate faster than estimates in Europe but slower than what is seen in the US generic market. (harvard.edu)
• Allowing manufacturers to market a biosimilar closer to its approval date could decrease confusion when the agent becomes available, said Angus Worthing, MD, a rheumatologist in Chevy Chase, Maryland, who is chair of the government affairs committee at the American College of Rheumatology. (medscape.com)
• The acquisition will mark Eagle's entry into biologics, the fastest growing sector of the pharmaceuticals market, and will allow the Company to apply its proven market strategy to offer "biobetter" formulations, and to aid in the rapid development of novel biologics. (eagleus.com)
• Biologics are a multi-billion-dollar sector of the global pharmaceuticals market and we are fortunate to be collaborating with some of the world's leading minds in the field. (eagleus.com)
• Currently, the market is dominated by oral antimuscarinics, a highly genericized drug class, as well as two oral beta 3 adrenergic receptor agonists, Astellas' Myrbetriq (mirabegron) and vibegron (marketed as Gemtesa in the US by Urovant Sciences and as Beova in Japan by Kyorin Pharmaceutical). (pharmaceutical-technology.com)
• The pharmaceutical excipients market in Argentina is expected to grow at the highest CAGR during the forecast period. (marketsandmarkets.com)
• The pharmaceutical excipients market in Argentina is mainly driven by the rising production & consumption of pharmaceutical products, large pool of domestic pharmaceutical manufacturers, rising pharmaceutical expenditure, growing investments by multinational market players in Argentina, growing production of biosimilar products, and rising burden of diseases. (marketsandmarkets.com)
• The company also pursues the strategy of agreements and partnerships with well-known science and technology universities to enhance its presence in the pharmaceutical excipients market. (marketsandmarkets.com)
• The pharmaceutical drugs and biologics market consists of sales of pharmaceutical drugs and biologics logistics services by entities (organizations, sole traders and partnerships) that provide pharmaceutical drugs and biologics logistics services. (thebusinessresearchcompany.com)
• Factors that could hinder the growth of the pharmaceutical drugs and biologics logistics market in the future include underdeveloped logistics infrastructure, skill shortages, reduction in free trade, and development of oral biologics. (thebusinessresearchcompany.com)
• The improving consistency and efficiency of logistics service providers is expected to drive the pharmaceutical drugs and biologics logistics market. (thebusinessresearchcompany.com)
• These constant and reliable services offered by logistics service providers will enable pharmaceutical and biologics companies to achieve efficiencies in domestic and international markets, thereby improving overall market growth. (thebusinessresearchcompany.com)
• Lack of developed logistics infrastructure is expected to limit the growth of the market for pharmaceutical drugs and biologics logistics market in the forecast period. (thebusinessresearchcompany.com)
• This is the challenge facing pharmaceutical companies that want to market biosimilars. (mcgill.ca)
• Voisin Consulting Life Sciences (VCLS) is a regulatory science and market access advisory consulting firm assisting Biotechnology, Pharmaceutical, and MedTech companies and manufacturers throughout product development, market access, and life cycle management. (nih.gov)

Products7

• The European Congress kicked off in the wake of the US Supreme Court decision and had meeting attendees talking about the fact that manufacturers developing biosimilar agents no longer need to wait for approval from the US Food and Drug Administration (FDA) to start marketing products. (medscape.com)
• Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. (migentra.com)
• KENILWORTH, N.J.-( BUSINESS WIRE )-Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced its intention to spin-off products from its Women's Health, trusted Legacy Brands, and Biosimilars businesses into a new, yet-to-be-named, independent, publicly traded company. (merck.com)
• The Food and Drug Administration (FDA) protects the public health by ensuring that pharmaceutical drug products intended to be marketed in the United States are safe and effective for their intended use. (nih.gov)
• Specifically, under the proposed commitments outlined in the third proposed Biosimilar User Fee Act (BSUFA) commitment letter , FDA is exploring ways to enhance biosimilar and interchangeable biosimilar product development and regulatory science, specifically in the areas of 1) improving the efficiency of biosimilar product development and 2) advancing the development of interchangeable products. (nih.gov)
• 1) Improving the efficiency of biosimilar products development. (nih.gov)
• Conclusion: The prices of original products, for most of the inputs, are lower than those of biosimilars, reversing the international logic. (who.int)

Merck1

• Merck offered a 35% discount with the first biosimilar approved in the United States," Reilly reported. (medscape.com)

Generics1

• Bioventure , a subsidiary of Yas Holding 's Healthcare Division, GlobalOne Healthcare Holding (GHH) , specializes in biosimilars and speciality generics, in/out-licensing, tech transfer, and investment in disruptive healthtech, medtech and biotechnology solutions. (migentra.com)

Alvotech3

• According to the agreement, Minapharm Pharmaceuticals and MiGenTra GmbH will share responsibilities in the Territory to file, launch and commercialize Alvotech's portfolio of licensed biosimilars once approved, under Bioventure's exclusive strategic partnership with Alvotech in the region. (migentra.com)
• Bioventure is currently the Middle East and Africa's exclusive license holder for a comprehensive portfolio of biosimilar candidates developed and manufactured by Alvotech, a global biotech company headquartered in Iceland. (migentra.com)
• Under the partnership, the biosimilars will be developed and supplied by Alvotech while Advanz Pharma will be responsible for registration and marketing in Europe. (pharmaceutical-business-review.com)

Innovator1

• That is especially true when there is a small spread in price between an innovator product and a biosimilar. (medscape.com)

Understanding1

• 2. European Stakeholder Learnings Regarding Biosimilars: Part I-Improving Biosimilar Understanding and Adoption. (nih.gov)

Markets3

• Nevertheless, there is little competition in these markets from biosimilars, which are like generic versions of biologics that can drive prices down. (harvard.edu)
• Growth in the historic period resulted from Increase in pharmaceutical sales, healthcare reforms, increase in outsourcing in the pharmaceutical industry, rapid growth in elderly population, strong economic growth in emerging markets, and rise in healthcare expenditure. (thebusinessresearchcompany.com)
• 13. Identifying Key Benefits in European Off-Patent Biologics and Biosimilar Markets: It is Not Only About Price! (nih.gov)

Healthcare2

• With investments in leading bio-pharmaceuticals and innovative manufacturing solutions, GHH is delivering on its commitment to improve healthcare outcomes and patient quality of life. (migentra.com)
• 15. Biosimilars for inflammatory bowel disease: how can healthcare professionals help address patients' concerns? (nih.gov)

Insulin1

• Gan & Lee Pharmaceuticals announced positive Ph I results for its three proposed insulin analog biosimilars (insulin aspart, insulin lispro and insulin glargine). (pearceip.law)

Adoption1

• These results add further to the current evidence on pegfilgrastim biosimilars and support wider adoption of pegfilgrastim biosimilars among payers, providers, and patients . (bvsalud.org)

Companies4

• Importantly, Arsia currently has several early stage partnerships with pharmaceutical companies. (eagleus.com)
• It permits pharmaceutical companies to create uniformity and efficiency throughout the distribution chain network. (thebusinessresearchcompany.com)
• To uphold momentum in outsourced services for pharmaceutical companies, the logistics service provider needs to protect the confidentiality of the proprietary information, prove its trustworthiness in services, provide constant developments and comply with regulations. (thebusinessresearchcompany.com)
• In the area of biologics, one concern is that many of these antibodies are quite expensive to buy because they're patent protected, and pharmaceutical companies are trying to recoup their investment. (medlineplus.gov)

Autoimmune1

• Alvotech's current pipeline contains eight biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. (migentra.com)

Sciences3

• FIP makes it a priority to publish the latest developments in pharmacy practice and pharmaceutical sciences, related global news and prominent events. (fip.org)
• Dr. Beumer Sassi received her PhD in Pharmaceutical Sciences from the University of Pittsburgh, School of Pharmacy. (nih.gov)
• International Journal of Pharmacy and Pharmaceutical Sciences. (who.int)

Patients4

• Because of this decision, patients could have access to biosimilars sooner than they would have previously," Dr Worthing explained. (medscape.com)
• The aim of this study (Treatment Period 1) was to demonstrate equivalent efficacy, primarily based on the PASI75 response rate at Week 16, and similar safety of the proposed biosimilar GP2017 and Humira in patients with moderate to severe chronic plaque-type psoriasis at the end of Treatment Period 1, after 17 weeks of study treatment. (clinicaltrials.gov)
• 17. Consensus report: clinical recommendations for the prevention and management of the nocebo effect in biosimilar-treated IBD patients. (nih.gov)
• 18. Biosimilar Agents for Psoriasis Treatment: The Perspective of Portuguese Patients. (nih.gov)

Brazil2

• Alexandra held several positions at a generic pharmaceutical company in Brazil in quality control, formulation, and manufacturing. (nih.gov)
• Araujo R. L., Mosegui G. B. G., Vianna C. M. D. E. M., Villar F. A., Catao T. P.. Reflections And Perspectives On Biosimilars In Brazil. (who.int)

Therapeutic1

• Licensed biosimilar candidates cover a wide range of therapeutic areas, all characterized by high unmet medical need in the Territory. (migentra.com)

Biotechnology2

• Eagle Pharmaceuticals ("Eagle" or the "Company") (NASDAQ:EGRX) today announced that it has signed a definitive agreement to acquire Arsia Therapeutics ("Arsia"), an early-stage biotechnology firm with proprietary viscosity-reducing technology and formulation know-how. (eagleus.com)
• Pharmaceutical drugs used to be small, but the biotechnology revolution changed the game. (mcgill.ca)

CDMO1

• Moreover, it includes figures regarding international trade and some insights about the pharmaceutical CDMO. (statista.com)

Regulatory4

• Biosimilars marketed before the traditional 6-month waiting period still have to go through the same regulatory approval process. (medscape.com)
• 4. Regulatory Information and Guidance on Biosimilars and Their Use Across Europe: A Call for Strengthened One Voice Messaging. (nih.gov)
• 6. Global Acceptance of Biosimilars: Importance of Regulatory Consistency, Education, and Trust. (nih.gov)
• The purpose of this Funding Opportunity Announcement (FOA) is to support research projects that enhance biosimilar and interchangeable biological product development and regulatory science. (nih.gov)

PHARMACY2

• Pharmacy Service, Hospital, Pharmaceutical. (frontiersin.org)
• Department of Pharmaceutical Outcomes and Policy, College of Pharmacy. (bvsalud.org)

Biotech1

• Dr. Wafik Bardissi, Chief Executive Officer of Minapharm Pharmaceuticals, said: 'Minapharm has provided advanced proprietary technologies to the global biotech industry coupled with end-to-end manufacturing and commercialization expertise for more than two decades. (migentra.com)

Approval3

• The Biosimilars Act provides a pathway for biosimilars to achieve quicker and less expensive FDA approval than what is required for a new biopharmaceutical. (ssrn.com)
• If we are serious about reducing the price of biological drugs and encouraging the creation of biosimilars, we will need to develop a more effective pathway for approval. (ssrn.com)
• The greater risks associated with the production of biosimilars should prompt a fair degree of caution in establishing the pathway for approval. (ssrn.com)

Drugs2

• Pharmaceutical prices in the US continue to increase every year with many drugs known as biologics leading the way. (harvard.edu)
• Congress recently passed the Biosimilars Act in an attempt to replicate the success that generic small molecule drugs have enjoyed under the Hatch-Waxman Act. (ssrn.com)

News1

• Brief pharmaceutical news items for October 2009. (pharmtech.com)

Company2

• Biosimilar is referred to a medical product that is similar to existing drug produced by a well-established company. (biospace.com)
• The company is largely known for its diversified cellulose compound offerings for the pharmaceutical industry. (marketsandmarkets.com)

Development3

• The Article identifies areas of uncertainty and other aspects of the current regime that create disincentives for the development of biosimilars, as well as suggesting improvements. (ssrn.com)
• FDA has been encouraging drug sponsors to use a systematic approach such as quality-by-design principles for pharmaceutical development. (pharmtech.com)
• FDA stakeholders are exploring innovative ways to produce scientific evidence in support of biosimilar and interchangeable product development. (nih.gov)

Global3

• The countries of Central and Eastern Europe and the Commonwealth of Independent States are closing in on global pharmaceutical competition. (pharmtech.com)
• Prominent players in the global Latin America pharmaceutical excipients industry are DowDuPont (US), Roquette (France), Ashland (US), BASF (Germany), and Kerry Group (Ireland). (marketsandmarkets.com)
• Its position among the top five pharmaceutical excipient manufacturers is attributed to its global footprint through distributors and agents. (marketsandmarkets.com)