The first interchangeable biosimilar insulin to treat diabetes has been approved by the US Food and Drug Administration.
According to an exchange filing, Semglee will be manufactured by Biocon Biologics Ltd., a subsidiary of Biocon, and marketed by Viatris Inc. (formerly Mylan Pharmaceuticals Inc.) in the United States, where more than 3.4 crore individuals suffer from this condition. It helps adults with Type 2 diabetes and adults and children with Type 1 diabetes manage their blood sugar levels.
This product can be substituted for its reference drug Lantus, an insulin-glargine manufactured by Sanofi, at pharmacies without the intervention of the prescriber, the filing said. It’s much like how generic drugs are substituted for brand name drugs. “The company [Biocon] is eligible to have exclusivity for 12 months before the U.S. Food and Drug Administration can approve another biosimilar interchangeable to Lantus. Commercial preparations for launch are underway.”