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  • Biocon Biologics and Viatris Inc. receive FDA appr...

Biocon Biologics and Viatris Inc. receive FDA approval for first interchangeable biosimilar Semglee

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Published:2nd Aug 2021
Biocon Biologics Ltd. (a subsidiary of Biocon Ltd.) and Viatris Inc. have announced that the FDA has approved Semglee (insulin glargine-yfgn injection) as the first interchangeable biosimilar product under the 351(k) regulatory pathway.

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. 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.

The "interchangeable" description ensures the drug can be directly substituted by pharmacists for Sanofi's Lantus. While the FDA has approved 29 other biosimilars, none have been awarded the coveted designation, which allows pharmacists to directly swap in a biosimilar version of a branded biologic.

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.

Condition: Diabetes Types 1 & 2
Type: drug

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