FDA Issues Final Guidance on Postapproval Manufacturing Changes for Biosimilar and Interchangeable Biosimilar Products

FDA issued on October 9 the final guidance "Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products — Questions and Answers," revised from the 2024 draft of the same name. The guidance answers common regulatory questions about postapproval manufacturing process changes for biosimilar and interchangeable biosimilar products. It creates no rights, is not legally binding on FDA or the public, and applicants may use alternative approaches that meet applicable regulatory requirements.