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USFDA Guidance: Labeling for Biosimilar & Interchangeable Biosimilar Products

Earlier this Monday (18 September 2023), The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research released draft guidance "Labeling for Biosimilar and Interchangeable Biosimilar Products" and final guidance "Additional Draft Q&As on Biosimilar Development and the BPCI Act".

Biosimilarity means “that the biological product is highly similar to the reference product not withstanding minor differences in clinically inactive components” and that “there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.”

The purpose of this guidance is to assist applicants in developing draft labeling for proposed biosimilar and interchangeable biosimilar products to be submitted under section 351(k) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(k)) (351(k) application.

This guidance only recommends labeling biosimilar and interchangeable biosimilar products based on the prescribing information, with exceptions to certain recommendations in section V, FDA-Approved Patient Labeling of Biosimilar and Interchangeable Biosimilar Products, pertaining to FDA-approved patient labels (e.g., Patient Information, Medication Guide, Use Instructions).

New 351(k) applications and supplement submissions for biosimilar and interchangeable biosimilar product labeling should include the following:

  • A clean version of reference product labeling that was used to develop the biosimilar or interchangeable biosimilar product labeling

  • A tracked-changes and annotated version of proposed biosimilar or interchangeable biosimilar product labeling explaining the differences from the reference product labeling

  • A clean version of the proposed biosimilar or interchangeable biosimilar product labeling

The draft guidance document provides answers to common questions regarding the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) from prospective applicants.

The Question and answer (Q&A) formats are intended to inform prospective applicants, facilitate the development of proposed biosimilar products and interchangeable products, and describe the FDA’s interpretation of certain statutory requirements added by the BPCI Act.


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