FDA Issues Final Guidance to Manufacturers on Biosimilars' Pathway to Interchangeability

On May 10, the U.S. Food and Drug Administration (FDA) released its final guidance to drug manufacturers with direction on what studies need to show the agency in how a biosimilar is interchangeable with a biologic. The healthcare community, and specifically, the oncology community, has called upon the FDA and Congress to increase the availability and competition of biosimilars.  

Read statement from acting FDA Commissioner Ned Sharpless, MD.

Posted 5/13/2019