FDA’s New Biosimilarity Guidance Aims to Revolutionize Biologic Drug Market Access
The closing of the public comment period on January 20 for the U.S. Food and Drug Administration’s draft guidance on demonstrating biosimilarity marks a pivotal moment in the regulation of biosimilars. Released on October 29, 2025, the guidance outlines significant updates aimed at simplifying biosimilarity studies. These changes are intended to ease the pathway for…