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Not for implementation.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.
- Docket Number:
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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This draft guidance document revises the draft guidance document entitled “New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2),” issued December 12, 2018 to retain appropriate Q&As in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.
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:
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.