Opportunity
Federal Register #2026-20817
FDA final guidance on postapproval manufacturing changes to biosimilar products
Buyer
Department of Health and Human Services / Food and Drug Administration
Posted
October 13, 2026
Identifier
2026-20817
The FDA issued final guidance on manufacturing changes to licensed biosimilar products. - Government buyer: U.S. Department of Health and Human Services (HHS), Food and Drug Administration (FDA). - Notice purpose: Announces final industry guidance for postapproval manufacturing changes to licensed biosimilar and interchangeable biosimilar products; it is not a procurement opportunity. - Guidance details: Describes information FDA recommends for manufacturing changes across reporting categories, aligns with ICH Q5E principles, and clarifies recommendations for comparative analytical assessment data and information supporting certain supplement approvals. - Superseded guidance: Replaces prior FDA recommendations on this topic. - OEMs, vendors, products, quantities, and part numbers: None identified; no goods or services are being solicited.
Description
The FDA announced the availability of final industry guidance on postapproval manufacturing changes to biosimilar and interchangeable biosimilar products licensed under the Public Health Service Act. The guidance answers commonly asked questions from applicants and other interested parties and describes information recommended to support manufacturing changes across different reporting categories. It finalizes draft guidance issued July 23, 2024, and supersedes the recommendations in Q&A I.20 of FDA’s biosimilar development guidance. This is a notice of guidance availability, not a procurement solicitation.