New and Revised Draft Q&As on Biosimilar Development and the Biologics Price Competition and Innovation Act; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a revised draft guidance for industry entitled "New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4)." The question and answer (Q&A) format is intended to inform prospective applicants and facilitate the development of proposed biosimilar products and proposed interchangeable biosimilar products, as well as describe FDA's proposed interpretation of certain statutory requirements related to the abbreviated licensure pathway for biological products added by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). This draft guidance revises and replaces the draft guidance for industry entitled "New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 3)" issued September 17, 2021 to provide certain revisions to Q&As I.8, I.10, and I.19, which have been withdrawn from the final guidance entitled "Questions and Answers on Biosimilar Development and the BPCI Act" issued September 20, 2021.
Abstract as published in the Federal Register.
The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.
View on federalregister.gov →Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.