Questions and Answers on Biosimilar Development and the BPCI Act

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

• Content current as of:

  03/08/2026

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