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# Streamline and Update Biosimilar Development: Council
- URL: https://www.fdaweb.com/streamline-and-update-biosimilar-development-council/
- Published: 2024-06-04T12:00:00.000Z
- Updated: 2026-09-14T14:32:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157109

The Biosimilars Council, a division of the Association for Accessible Medicines, says the biosimilar development paradigm in the U.S. should be updated and streamlined to reflect new scientific understandings. In a position [paper](https://biosimilarscouncil.org/wp-content/uploads/2024/05/202405-BiosimilarsCouncil-Streamlining-Development-Biosimilar-Medicines.pdf?ref=fdaweb.com), the council says an updated development paradigm “must account for scientific advances that allow for the elimination of unnecessary regulatory requirements, such as clinical efficacy studies, when data from analytic and pharmacokinetic studies have already demonstrated there are no clinically meaningful differences between the biosimilar and its reference product.”

The council says analytic methods are now sensitive enough to detect small differences between a biosimilar and a reference product, differences that previously might have created sufficient residual uncertainty for FDA to request comparative studies.

The council makes these recommendations for FDA:

- eliminate unnecessary clinical efficacy studies; and
- establish global regulatory comparators to support a demonstration of biosimilarity.

“Streamlining the biosimilar program using robust scientific tools and advanced analytical methodology will help to make high-quality biosimilars available for patients more quickly and at a lower cost, without any difference in safety or effectiveness,” the council concludes.