Biocon Biologics and Viatris get USFDA approval for First Interchangeable Biosimilar Semglee injection for Diabetes Treatment

BENGALURU : Biocon Biologics Ltd. and Viatris Inc. on Thursday announced that the U.S. Food and Drug Administration (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 canapprove another biosimilar interchangeable to Lantus. Commercial preparations for launchare underway. Over the next few months, Viatris will transition the current product to the 351(k) interchangeable product.

“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 willallow pharmacy level substitution and thereby provide convenient and affordable access to Semglee, a quality Biosimilar Insulin Glargine” Biocon Biologics, Executive Chairperson, Kiran Mazumdar-Shaw said.

“This interchangeability approval for Semglee by the U.S. FDA, another first to our credit, is a testament to ourscientific 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” Biocon Biologics Managing Director Arun Chandavarkar said.