Mylan’s Semglee Becomes First Interchangeable Biosimilar In The U.S.

FDA on Wednesday (July 28) approved the first interchangeable biosimilar product, Mylan’s Semglee (insulin glargine-yfgn) for treatment of diabetes, which is biosimilar to and interchangeable with its reference product, Sanofi’s Lantus (insulin glargine). The approval of the first interchangeable biosimilar in the United States has the potential to “greatly reduce health care costs,” acting FDA chief Janet Woodcock said. The approval comes just weeks after President Joe Biden issued an executive order urging FDA and CMS to take steps...