The approval allows for substitution at the pharmacy counter for Lantus, its reference product.
The FDA has approved the first biosimilar insulin to improve glycemic control in adults and pediatric patients with type 1 diabetes and in adults with type 2 diabetes.
Developed by Mylan Pharmaceuticals, now Viatris, in partnership with Biocon Biologics, Semglee (insulin glargine-yfgn) is interchangeable with its reference product, Sanofi’s Lantus (insulin glargine), a long-acting insulin analog. Semglee is the first interchangeable biosimilar product approved in the United States for the treatment of diabetes.
Semglee, offered in 10 mL vials and 3 mL prefilled pens, is administered subcutaneously once daily. It is not recommended for treating diabetic ketoacidosis. In a statement, Viatris officials said commercial preparations for launch are under way.
FDA officials noted that biosimilars typically have launched with initial list prices 15% to 35% lower than comparative list prices of the reference products.
Viatris and Biocon Biologic's insulin glargine has received regulatory approval in more than 60 countries around the world and was the third product approved by the FDA through the Viatris-Biocon Biologics collaboration. The company is eligible to have exclusivity for 12 months before the FDA can approve another biosimilar interchangeable to Lantus.
Viatris was formed in November 2020 after the merger of Mylan and Pfizer’s Upjohn business and has U.S. headquarters in Pittsburgh, Pa.