FDA

FDA moves to accelerate biosimilar development, cut drug costs

October 31, 2025

FDA announced new steps to make biosimilar development faster and less costly, aiming to expand access to lower-cost alternatives to biologic drugs for serious and chronic conditions. The agency's new guidance reduces the resource-intensive requirement for developers to conduct comparative human clinical studies, allowing them to rely instead on analytical testing to demonstrate product differences.

Biologics account for just 5% of U.S. prescriptions but 51% of drug spending. Although FDA has approved 76 biosimilars, their market share remains under 20%, and only about 10% of biologics expected to lose patent protection in the next decade have biosimilars in development. FDA’s action is intended to accelerate development, promote competition, and expand patient options without compromising safety or effectiveness.

Source:

(2025, October 29). FDA. FDA Moves to Accelerate Biosimilar Development and Lower Drug Costs. https://www.fda.gov/news-events/press-announcements/fda-moves-accelerate-biosimilar-development-and-lower-drug-costs