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Viatris Gets FDA Approval For Interchangeable Biosimilar Semglee For Diabetes Treatment

Viatris Inc. (VTRS) and Biocon Biologics said that they received an approval from the U.S. Food and Drug Administration for the first Interchangeable Biosimilar Semglee (insulin glargine-yfgn injection) for the treatment of diabetes.

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.

Viatris said it is eligible to have exclusivity for 12 months before the FDA can approve another biosimilar interchangeable to Lantus. Commercial preparations for launch are underway. Over the next few months, Viatris will transition the current product to the 351(k) interchangeable product.

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.

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.

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