The company is eligible to have exclusivity for 12 months before the FDA can approve another biosimilar interchangeable to Lantus
Hyderabad: Biocon Biologics Ltd and Nasdaq-listed Viatris Inc on Thursday said the USFDA has approved Semglee, the interchangeable biosimilar insulin product co-developed by them, for the treatment of diabetes in the US.
The approval for the 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 two companies said in a statement.
"The United States Food and Drug Administration has approved Semglee (insulin glargine-yfgn injection) as the first interchangeable biosimilar product under the 351(k) regulatory pathway," the statement said,.
The company is eligible to have exclusivity for 12 months before the FDA can approve another biosimilar interchangeable to Lantus. Comm-ercial preparations for launch are underway.
In a few months, Viatris will transition the current product to the interchangeable product, it said.
"It is a milestone achievement for both Biocon Bio-logics and our partner Viatris," Biocon Biologics éxecutive chairperson, Ki-ran Mazumdar-Shaw said.