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GUIDANCE DOCUMENT

Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers October 2026

Download the Final Guidance Document Read the Federal Register Notice
Final Level 1 Guidance
Docket Number:
FDA-2024-D-2581
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

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  This guidance finalizes the draft guidance of the same title issued on July 23, 2024.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2024-D-2581.

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