FDA issues post-workshop strategy document on Future Needs for the Development of Interchangeable Biosimilar Products

The U.S. Food and Drug Administration (FDA) issued a draft strategy document “BsUFA III Future Needs for the Development of Interchangeable Products” BsUFA III Future Needs for the Development of Interchangeable Products” based on the scientific workshop held on September 19, 2025, and comments submitted to the public docket following the workshop.