FDA Moves to Accelerate Biosimilar Development
October 29, 2025
The FDA announced plans to expedite the development of biosimilar medications to introduce more, lower cost drugs to the market and help treat serious and chronic disease. In a new draft guidance, the FDA proposes major updates to simplify biosimilarity studies and reduce clinical testing. The FDA's new guidance reduces the requirements for developers to conduct comparative human clinical studies, allowing them to rely instead on analytical testing to demonstrate product differences. The FDA also plans to make it easier for biosimilars to be developed as interchangeable with brand-name biologics. According to the FDA, biologic medications make up 5% of prescriptions in the U.S. but account for 51% of total drug spending as of 2024.
