New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4) Draft Guidance for Industry March 2026

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/new-and-revised-draft-qas-biosimilar-development-and-bpci-act-revision-4?utm_medium=email&utm_source=govdelivery FDA Issues Draft Guidance for Industry, “New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4)” Today, FDA released a draft guidance for industry “New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4).” The question and answer (Q&A) format is intended to inform prospective applicants and facilitate the development of proposed biosimilars and proposed interchangeable biosimilars, as well as describe FDA’s interpretation of certain statutory requirements in the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). This draft guidance (Revision 4) revises and replaces the draft guidance for industry entitled “New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 3)” issued September 17, 2021, and includes revisions to certain Q&As that appeared in a previous version of the final guidance entitled “Questions and Answers on Biosimilar Development and the BPCI Act.” FDA is issuing this draft guidance (Revision 4) to provide updated recommendations to prospective biosimilar applicants seeking to use a comparator product approved outside the U.S. (“non-U.S.-licensed comparator product”) to support a demonstration that the proposed product is biosimilar to the U.S.-licensed reference product. Specifically, the updated recommendations in revised draft Q&A I.8 describe scenarios in which a biosimilar applicant may scientifically justify the relevance of comparative clinical data from a study using a non-U.S.-licensed comparator product based on analytical data and without additional data from a three-way clinical pharmacokinetics (PK) study (using the proposed biosimilar, the U.S.-licensed reference product, and the non-U.S.-licensed comparator product). The revisions to draft Q&A I.8 also remove the earlier recommendation for at least one clinical PK study that directly compares the proposed biosimilar with the U.S.-licensed reference product to support a demonstration of biosimilarity. In addition, FDA has made conforming and clarifying revisions to two other Q&As (I.10 and I.19) that contemplated a three-way clinical PK study to justify use of a non-U.S.-licensed comparator product and is including these revised Q&As in Revision 4 of the draft guidance. The draft guidance (Revision 4) also includes Q&A I.12, which has not been changed and is carried over from Revision 3 of the draft guidance. The Agency is reissuing the final guidance entitled “Questions and Answers on Biosimilar Development and the BPCI Act” for the purpose of withdrawing the particular Q&As that currently are being revised. FDA continues to evaluate other Q&As in this final guidance as part of its efforts to further enhance efficiency in biosimilar development programs and intends to update any Q&As that may no longer reflect the Agency’s current thinking, as appropriate. Additionally, the final guidance “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product” issued April 30, 2015, is being withdrawn because it no longer represents FDA’s current thinking. FDA has issued more recent guidance documents (search “biosimilars” under topics) that include recommendations on topics that previously were addressed in the Scientific Considerations Guidance and are intended to facilitate biosimilar development programs. For instructions on how to submit comments on the draft guidance, see the Federal Register Notice. The draft guidance (Revision 4), when finalized, will represent the current thinking of FDA on these topics.