The Complete Guide to Monoclonal Antibody and Granulocyte-Colony Stimulating Factor Biosimilars Approved in the United States and European Union
Reviewed by Joseph P. Fuhr, Jr., PhD, professor emeritus, Widener University
Note: In the United States, products such as insulin, enoxaparin sodium, and hormones are regulated under the Federal Food, Drug and Cosmetic Act, not under the Public Health Service Act. While follow-ons of these products may be declared biosimilars in other regulatory territories (including the European Union), in the United States, follow-ons of these products are not subject to the Biologics Price Competition and Innovation Act’s pathway for biosimilar approval.
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AMCP Posters Tackle Interchangeability and Medicaid, Factors Driving Biosimilar Access
April 24th 2024Two posters from the Academy of Managed Care Pharmacy (AMCP) annual meeting explore how an interchangeable insulin glargine biosimilar plays into Medicaid budgets and the top factors driving access to biosimilars.
Sustainable Biosimilar Markets Achieve Widespread Market Uptake Through Collective Action
April 22nd 2024Despite current challenges in biosimilar market growth due to stakeholder disagreements, a recent commentary proposes that applying collective action theory can achieve widespread biosimilar market uptake by fostering collaboration for long-term benefits.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.