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# FDA Biosimilar Regulatory Science Program Opens
- URL: https://www.fdaweb.com/fda-biosimilar-regulatory-science-program-opens/
- Published: 2022-10-04T12:00:00.000Z
- Updated: 2026-09-14T18:01:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152883

As agreed to in the Biosimilar User Fee Act 3 reauthorization, FDA is launching a pilot regulatory science program to further advance biosimilar and interchangeable biological product development. A new program [Web site](https://www.fda.gov/drugs/biosimilars/biosimilars-science-and-research?utm%5Fmedium=email&utm%5Fsource=govdelivery) says the pilot will focus on enhancing regulatory decision-making and facilitating science-based recommendations in areas foundational to biosimilar and interchangeable product development.

The agency has issued a funding opportunity [announcement](https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-22-026.html?utm%5Fmedium=email&utm%5Fsource=govdelivery) to solicit projects that can help to advance the program goals.