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Product safetyFDAUnited StatesImports

Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers; Guidance for Industry; Availability

13 October 2026

In plain English

FDA announced final guidance answering common questions on postapproval manufacturing changes for biosimilar and interchangeable biosimilar products licensed under the PHS Act.

Read the official notice
Topic
Product safety
Regulator
FDA
Published
13 October 2026
For
Imports
Where it applies
United States
Source
FDA (Food and Drug Administration)

From the notice

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 Ac
The full text is at the source

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