Biosimilars

The Pharmacy Times® Biosimilars Resource Center is a comprehensive resource for clinical news and expert insights on issues related to biosimilar drugs, a biological product that is highly similar to a reference biologic for which there are no clinically meaningful differences in terms of safety, purity, and efficacy.

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US FDA homepage, biosimilars -- Image credit: IB Photography | stock.adobe.com
FDA Approves Bosaya and Aukelso, Biosimilars to Reference Denosumab

September 17th 2025

Additionally, the FDA granted a provisional interchangeability designation to both biosimilars.

Woman with inflammatory bowel disease (IBD) -- Image credit: SewcreamStudio | stock.adobe.com
Switching from Humira to Biosimilar Did Not Affect Disease Control, Quality of Life in IBD

September 11th 2025

Eye scan showing macular degeneration -- Image credit: Rabizo Anatolii | stock.adobe.com
Efficacy, Safety, and Immunogenicity Maintained When Patients With nAMD Switch from Eylea to Biosimilar

September 5th 2025

FDA waives clinical efficacy studies for certain biosimilars -- Image credit: Kamitana | stock.adobe.com
FDA to Waive Clinical Efficacy Studies for Monoclonal Antibody Biosimilars

September 2nd 2025

FDA approves 2 denosumab biosimilars, Bildyos and Bilprevda -- Image credit: gguy | stock.adobe.com
FDA Approves Bildyos and Bilprevda, Biosimilars of Reference Denosumab

September 2nd 2025

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