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Expert Analysis

FDA's Biosimilarity Guidance Holds Uncertain Implications

By Jason Doran, Richard Mortimer and John Jarosz ( March 2, 2026, 5:54 PM EST) -- On Jan. 20, the public comment period for the U.S. Food and Drug Administration's draft guidance on demonstrating biosimilarity closed.[1] This document, issued Oct. 29, 2025, proposes "major updates to simplify biosimilarity studies and reduce unnecessary clinical testing," while also making it "easier for biosimilars to be developed as interchangeable with brand-name biologics."[2]...

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