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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Biosimilars Gastroenterology Roundup: March 2025
April 1st 2025As the biosimilar industry celebrates a decade of growth, the market continues to evolve with expanded treatment options, cost savings, and a flurry of new competitors—yet regulatory challenges, market dynamics, and patient accessibility remain key hurdles to unlocking its full potential.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
PBM Evolution Toward Value-Based Care Shifts to Transparent Pharmacy Pricing
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