Government and private health-care program payers have been anxiously awaiting FDA action on biosimilars. Payers anticipate that the ability to substitute and dispense a biosimilar product in lieu of a more expensive prescribed biologic or specialty drug may save payment programs millions, if not billions, of dollars.

In order to freely substitute a biosimilar for a prescribed reference biological product, the FDA must determine that the biosimilar is interchangeable with the reference product.

Originally published in BNA’s Medicare Report on May 29, 2015.