Goodwin Procter·FDA / LIFE SCIENCES REGULATORY
FDA Finalizes Q&A on Postapproval Manufacturing Changes for Biosimilars
FDA's final Q&A guidance, announced October 13, 2026, sets out how sponsors must assess and report postapproval manufacturing changes to biosimilar and interchangeable biosimilar products.
fda-guidancebiosimilarsinterchangeable-biosimilarpostapproval-manufacturing-changesdrug-submissionschemistry-manufacturing-controls
Read the original firm alert → Wednesday, October 21, 2026