Viatris Inc. and Biocon Biologics Receive Historic Approval for First Interchangeable Biosimilar Semglee® (insulin glargine-yfgn injection) for the Treatment of Diabetes
The company is eligible to have exclusivity for 12 months before the FDA can approve another biosimilar interchangeable to Lantus.
- The company is eligible to have exclusivity for 12 months before the FDA can approve another biosimilar interchangeable to Lantus.
- Semglee is indicated to control high blood sugar in adults with Type 2 diabetes and adults and pediatric patients with Type 1 diabetes.
- Biocon Biologics, Executive Chairperson, Kiran Mazumdar-Shaw said: "We are extremely proud to be the first to obtain approval of an interchangeable Biosimilar product in the U.S.
- This will allow pharmacy level substitution and thereby provide convenient and affordable access to Semglee, a quality Biosimilar Insulin Glargine."