First Interchangeable Biosimilar Insulin Secures FDA Approval

August 2, 2021

The FDA has approved the first-ever interchangeable biosimilar insulin product, which could signal the beginning of the end for the soaring costs of insulin products.

“This is a momentous day for people who rely daily on insulin for treatment of diabetes, as biosimilar and interchangeable biosimilar products have the potential to greatly reduce healthcare costs,” said acting FDA Commissioner Janet Woodcock.

The product, Mylan Pharmaceuticals’ Semglee (insulin glargine-yfgn) is both biosimilar to and interchangeable with (can be substituted for) its reference product Lantus (insulin glargine), a long-acting insulin analog that got FDA approval in 2000. Semglee is now indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus.

The approval makes Mylan eligible for 12 months of first interchangeable exclusivity from the date of commercial launch. The company says Semglee will be introduced before the end of the year.

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