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GUIDANCE DOCUMENT

Questions and Answers on Biosimilar Development and the BPCI Act Guidance for Industry March 2026

Download the Final Guidance Document
Final Level 2 Revised Guidance
Docket Number:
FDA-2011-D-0611
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This guidance document provides answers to common questions from prospective applicants and other interested parties regarding the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The question and answer (Q&A) format is intended to inform prospective applicants and facilitate the development of proposed biosimilar and interchangeable biosimilar products, as well as describe FDA’s interpretation of certain statutory requirements added by the BPCI Act.

At this time, FDA is withdrawing Q&As I.8, I.10, and I.19 from the final guidance entitled “Questions and Answers on Biosimilar Development and the BPCI Act” issued September 20, 2021, and reissuing the final guidance (with certain updates to the introductory text) solely for the purpose of withdrawing these particular Q&As. The Agency 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.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2011-D-0611.

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