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On Jan. 20, the public comment period for the U.S. Food and Drug Administration's draft guidance on demonstrating biosimilarity closed.[1] This document, issued Oct. 29, 2025, proposes "major updates to simplify...
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