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The Top 5 Biosimilars Articles for the Week of February 3
The Center for Biosimilars® recaps the top stories for the week of February 3, 2020.
Hi, I’m Christina Mattina for The Center for Biosimilars®, your resource for clinical, regulatory, business, and policy news in the rapidly changing world of biosimilars.
Here are the top 5 biosimilars articles for the week of February 3, 2020.
Number 5: The European Medicines Agency’s Committee for Medicinal Products for Human Use recommends marketing authorization for Pfizer's Ruxience, a rituximab biosimilar.
Number 4: The FDA announces 6 final guidance documents on gene therapy manufacturing and clinical development of products, as well as a draft guidance regarding gene therapies and orphan drugs.
Number 3: In an effort to speed more generic drug approvals, the FDA says it is changing how it assigns priority review status to abbreviated new drug applications.
Number 2: Celltrion recalls its employees from China’s Wuhan province until the coronavirus outbreak is brought under control.
Number 1: Merck says it is spinning off its biosimilars business to focus on its oncology drug Keytruda.
To read all of these articles and more, visit centerforbiosimilars.com.
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?
How State Substitution Laws Shape Insulin Biosimilar Adoption
April 15th 2025States with fewer restrictions on biosimilar substitution tend to see higher uptake of interchangeable insulin glargine, showing how even small policy details can significantly influence biosimilar adoption and expand access to more affordable insulin.
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.
Experts Pressure Congress to Remove Roadblocks for Biosimilars
April 12th 2025Lawmakers and expert witnesses emphasized the potential of biosimilars to lower health care costs by overcoming barriers like pharmacy benefit manager practices, limited awareness, and regulatory delays to improve access and competition in chronic disease management during a recent congressional hearing.
