PK Studies in the Crosshairs: FDA Revises Biosimilar Development Guidance March 16, 2026 By Fabiola C. Gomez, Ph.D., CMC Regulatory Expert —

https://www.thefdalawblog.com/2026/03/pk-studies-in-the-crosshairs-fda-revises-biosimilar-development-guidance/?utm_source=rss&utm_medium=rss&utm_campaign=pk-studies-in-the-crosshairs-fda-revises-biosimilar-development-guidance The FDA continues to refine its approach to biosimilar development. On March 9, 2026, the Agency announced the release of the revised draft guidance titled “New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4).”