Home › Recently closed › 2026-04664
New and Revised Draft Q&As on Biosimilar Development and the Biologics Price Competition and Innovation Act; Draft Guidance for Industry; Availability
Read on FederalRegister.gov · Official PDF · Docket on Regulations.gov · Add to calendar (.ics)
Summary (from the Federal Register abstract)
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a revised draft guidance for industry entitled "New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4)."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 This draft guidance revises and replaces the draft guidance for industry entitled "New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 3)" issued September 17, 2021 to provide certain revisions to Q&As I.8, I.10, and I.19, which have been withdrawn from the final guidance entitled "Questions and Answers on Biosimilar Development and the BPCI Act" issued September 20, 2021.
- Document type
- Notice
- Federal Register document number
- 2026-04664
- Published
- Mar 10, 2026
- Action
- Notice of availability.
- Docket
- FDA-2011-D-0611
- Comments posted on Regulations.gov (at last check)
- 0
- DATES section (from the document)
- Submit either electronic or written comments on the draft guidance by May 11, 2026 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
- Topics (auto-tagged)
- Vaccines / biologics
Source: Federal Register API, document 2026-04664. Federal Register text is a U.S. government work. Confirm dates in the official document; later documents may extend, reopen or correct them.