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GUIDANCE DOCUMENT

Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers July 2024

Download the Draft Guidance Document Read the Federal Register Notice
Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2024-D-2581
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This guidance provides answers to commonly asked questions from applicants and other interested parties (collectively referred to as applicants throughout this guidance) regarding postapproval manufacturing changes (referred to as manufacturing changes throughout this guidance) made to licensed biosimilars and licensed interchangeable biosimilars. This question-and-answer (Q&A) guidance is intended to inform prospective and current applicants of the nature and type of information that applicants should provide in support of manufacturing changes to licensed biosimilars and licensed interchangeable biosimilars in different reporting categories.

Submit Comments

Submit Comments Online

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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