Biocon Biologics – a subsidiary of Biocon – and Viatris, on Thursday announced that the US Food and Drug Administration (USFDA) has approved Semglee (insulin glargine-yfgn injection) as the first interchangeable biosimilar product under the 351(k) regulatory pathway.
Semglee is indicated to control high blood sugar in adults with Type 2 diabetes and adults and pediatric patients with Type 1 diabetes. It is not recommended for the treatment of diabetic ketoacidosis. Semglee has an identical amino acid sequence to Lantus, and is approved for the same indications.
A statement from Biocon Biologics Executive Chairperson, Kiran Mazumdar-Shaw, said: “This will allow pharmacy-level substitution and, thereby, provide convenient and affordable access to Semglee, a quality Biosimilar Insulin Glargine.” Biocon Biologics Managing Director, Arun Chandavarkar, said: “This interchangeability approval for Semglee by the USFDA allows substitution at the pharmacy counter, thus expanding patient access and sets the stage for approvals for other insulin products.”
The interchangeable Semglee product, which will allow substitution of Semglee for the reference product, Lantus, at the pharmacy counter, will be introduced before the end of the year. The company is eligible to have exclusivity for 12 months before the FDA can approve another biosimilar interchangeable to Lantus.
Commercial preparations for launch are underway. Soon, Viatris will transition the current product to the 351(k) interchangeable product.