Biocon Biologics, Viatris get USFDA nod for first interchangeable biosimilar Semglee for 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.;
Bengaluru: Biocon Biologics Ltd. and Viatris Inc. today announced that the U.S. Food and Drug Administration (USFDA) has approved Semglee (insulin glargine-yfgn injection) as the first interchangeable biosimilar product under the 351(k) regulatory pathway.
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. It is a milestone achievement for both Biocon Biologics and our partner Viatris. 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, another first to our credit, is a testament to our scientific excellence and robust quality comparability data. This allows substitution at the pharmacy counter, thus expanding patient access and sets the stage for future approvals for our 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. Over the next few months, Viatris will transition the current product to the 351(k) interchangeable product.
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