FDA Approves First Interchangeable Biosimilar Insulin Product (UPDATE – 11/23/2021)

July 28, 2021 – the U.S. Food and Drug Administration (FDA) approved Viatris Inc.’s (formerly Mylan Pharmaceuticals Inc.) SEMGLEE (insulin glargine-yfgn), a biosimilar to LANTUS (insulin glargine). According to the press release, SEMGLEE is indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus.

SEMGLEE was further granted interchangeable status to the long-acting insulin analog. According to the FDA, SEMGLEE is the first insulin biosimilar with interchangeable status, which means that it may be substituted for the LANTUS reference product at the pharmacy without the intervention of the prescriber. The interchangeable designation was based on the FDA’s “rigorous approval standards,” including evidence that showed the reference product and biosimilar are highly similar and have no clinically meaningful differences in terms of safety, purity and potency. Further, the FDA expects both products to produce the same clinical result in any given patient and that the risks in terms of safety or diminished efficacy of switching between the biosimilar and reference product is not greater than the risk of using the reference product without such switching.

UPDATE (11/23/2021): On November 16, 2021, SEMGLEE launched in the U.S. as the first-ever interchangeable biosimilar.