- Bone Health
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The Complete Guide to Monoclonal Antibody and Granulocyte-Colony Stimulating Factor Biosimilars Approved in the United States and European Union
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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Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Biosimilar Approvals Streamlined With Advanced Statistics Amidst Differing Regulatory Requirements
February 25th 2025The FDA and European Medicines Agency (EMA) mandate high similarity between biosimilars and reference products, but their regulatory processes differ, especially with multiple reference products.
Biosimilars in Action: Market Shifts, Legal Insights, and FDA Approvals
February 9th 2025In this episode of Not So Different, host Skylar Jeremias covers the latest biosimilar developments, including new FDA approvals, patent disputes, and biosimilar market trends shaping the health care landscape.
Resolution of Injection Site Reactions After Switching to Adalimumab Biosimilar
February 22nd 2025A 15-year-old girl with ulcerative colitis who developed injection site reactions to the adalimumab reference product was successfully switched to the biosimilar LBAL without recurrence of symptoms, demonstrating the safety and effectiveness of switching for medical reasons, likely due to an allergic reaction to an excipient in the originator.
