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# Q&A Guide on Biosimilar Development
- URL: https://www.fdaweb.com/q-a-guide-on-biosimilar-development-2/
- Published: 2018-12-12T12:00:00.000Z
- Updated: 2026-09-15T00:50:41.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5143017

*Federal Register* notice: FDA has made available a final guidance entitled “Questions and Answers on Biosimilar Development and the BPCI Act.” The document is intended to inform prospective applicants and facilitate the development of proposed biosimilars and proposed interchangeable biosimilars, as well as to describe FDA’s interpretation of certain statutory requirements added by the Biologics Price Competition and Innovation Act of 2009\. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-12-12/pdf/2018-26853.pdf?ref=fdaweb.com).