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.

Latest News

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

This decision is believed to redefine how biological drugs will be developed, approved, and made affordable for patients.

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

Adalimumab (Humira) biosimilar (Hyrimoz) -- Image credit: luchschenF | stock.adobe.com
Switching From Reference Adalimumab to Biosimilar Shows No Major Differences in Patients With RA, PsA

August 28th 2025

Denosumab (Xgeva) -- Image credit: Tenacity_1987 | stock.adobe.com
LY01011, Biosimilar of Denosumab, Meets Primary End Point in Study

August 26th 2025

GLP-1 dulaglutide (Trulicity) -- Image credit: Edugrafo | stock.adobe.com
Dulaglutide Biosimilar Achieves Equivalent Efficacy in HbA1c Reduction in Patients With T2DM

August 22nd 2025

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