federal_register: 2021-20255

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2021-20255 Questions and Answers on Biosimilar Development and the Biologics Price Competition and Innovation Act of 2009; Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised final guidance for industry entitled "Questions and Answers on Biosimilar Development and the BPCI Act." The question and answer (Q&A) format is intended to inform prospective applicants and facilitate the development of proposed biosimilars and proposed interchangeable biosimilars, and also describes FDA's interpretation of certain statutory requirements added by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). This guidance document revises the final guidance document entitled "Questions and Answers on Biosimilar Development and the BPCI Act" issued December 12, 2018. 2021-09-20 2021 9 https://www.federalregister.gov/documents/2021/09/20/2021-20255/questions-and-answers-on-biosimilar-development-and-the-biologics-price-competition-and-innovation https://www.govinfo.gov/content/pkg/FR-2021-09-20/pdf/2021-20255.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised final guidance for industry entitled "Questions and Answers on Biosimilar Development and the BPCI Act." The question and answer (Q&A) format is intended to...

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