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# Biosimilar Postapproval Manufacturing Change Guide
- URL: https://www.fdaweb.com/biosimilar-postapproval-manufacturing-change-guide/
- Published: 2024-07-22T12:00:00.000Z
- Updated: 2026-09-14T14:36:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157395

FDA has posted a [draft guidance](https://www.fda.gov/media/180206/download?ref=fdaweb.com) entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products; Questions and Answers.” The document provides answers to common questions from applicants and other interested parties about postapproval manufacturing made to licensed biosimilars and interchangeable biosimilars. It is intended to inform applicants about the nature and type of information that they should provide to support such manufacturing changes in different reporting categories.

Under FDA’s regulations, applicants must tell the agency about each change in the product, production process, quality controls, equipment, facilities, or responsible personnel. Additionally, before distributing a product that has been changed, an applicant must assess the effects of the change and demonstrate through appropriate validation or other clinical/nonclinical laboratory studies the lack of unintended effects from the change on the identity, strength, quality, purity, or potency of the product as these factors may relate to the safety or effectiveness of the product. They must also inform FDA about each labeling change in the approved BLA.