The FDA approved Nufymco as an interchangeable biosimilar to Lucentis, making it the second approved ranibizumab biosimilar ...

The proposed aflibercept biosimilar, which references Regeneron’s Eylea, is a vascular endothelial growth factor receptor Fc ...

The U.S. Food and Drug Administration (FDA) has approved Merilog, a biosimilar to the widely used insulin product Novolog (insulin aspart), to enhance glycemic control in adults and children with ...

Approvals expand Amneal’s biosimilars portfolioCompany expects to commercialize six biosimilars across eight presentations by 2027 BRIDGEWATER, N.J., Dec. 22, 2025 (GLOBE NEWSWIRE) -- Amneal ...

German biosimilars specialist Formycon (FWB: FYB) has won US approval for Nufymco (ranibizumab), an interchangeable ...

The FDA has decided that biosimilar medications must have unique naming features, distinguishing them from brand-name biologics in a move to improve patient safety, according to a STAT news report. 1.

The FDA has approved Poherdy (pertuzumab-dpzb), the first interchangeable biosimilar to Perjeta (pertuzumab). Poherdy, as approved, is indicated for use in adults with HER2-positive breast cancer, ...

This effort to accelerate development can be clearly seen in how the agency is approaching biosimilars. In October 2025, the FDA issued a guidance update indicating that “switching” studies — a trial ...

In a Q&A, an FDA spokesperson discusses efforts to reduce misinformation about biosimilars through education, the agency’s collaboration with global regulators to streamline development, and its work ...