GUIDANCE DOCUMENT
Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act (Revision 1) Draft Guidance for Industry September 2023
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- FDA-2011-D-0611
- Issued by:
-
Guidance Issuing OfficeCenter for Drug Evaluation and ResearchCenter for Biologics Evaluation and Research
This draft guidance document provides answers to common questions from prospective applicants and other interested parties regarding the Biologics Price Competition and Innovation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 This draft guidance document revises the draft guidance document entitled “Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act,” issued November 2020 to retain appropriate Q&As in draft.
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