Accelerating Biosimilar Development: A Key Move by the FDA
On October 29, 2025, the FDA announced that it is taking major steps to make it faster and less costly to develop biosimilar medicines—the lower-cost alternatives to biologic drugs that treat many serious and chronic diseases. U.S. Food and Drug Administration+2U.S. Food and Drug Administration+2 Specifically, the agency released a draft guidance titled “Scientific Considerations […]