On 13 October 2026, the FDA published its final guidance for “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products“ on the Federal Register for industry stakeholders. This finalises draft guidance which was issued on 23 July 2024, fulfilling a commitment made in the 2022 reauthorisation of the Biosimilar User Fee Act.
The guidance provides manufacturers with non-binding recommendations on the nature and type of information that should be provided to the FDA to support post-approval manufacturing changes of licensed biosimilar and interchangeable biosimilar products.
The FDA considered comments received on the draft and made the following changes when finalising the guidance: “(1) further aligning recommendations in the guidance with the principles in International Council for Harmonisation (ICH) industry guidance entitled “Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process” (ICH Q5E); (2) clarifying recommendations for leveraging comparative analytical assessment data from an original 351(k) biologics license application (BLA); and (3) clarifying edits to Q&A 4 on the nature and type of information that FDA recommends to support approval of a supplement for a dosage form or a strength that has not previously been licensed under the 351(k) BLA.”