GUIDANCE DOCUMENT
New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 3) Draft New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 3).” September 2021
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
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Guidance Issuing OfficeCenter for Drug Evaluation and ResearchCenter 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 products and proposed interchangeable products, as well as describe FDA’s interpretation of certain statutory requirements added by the BPCI Act.
This draft guidance document revises the draft guidance document entitled “New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2),” issued December 12, 2018 to retain appropriate Q&As in draft.