Issue Date: October 13, 2026
Issued by: Center for Drug Evaluation and Research
Topic(s): Biosimilars
Status: Final
Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers.” This guidance provides answers to commonly asked questions from applicants and other interested parties regarding postapproval manufacturing changes made to biosimilar and interchangeable biosimilar products licensed under the Public Health Service Act (PHS Act). This guidance finalizes the draft guidance of the same title issued on July 23, 2024.
Download the Guidance Document
