U.S. FDA approves Biocon’s insulin Semglee

An employee of Biocon Ltd works inside the company's research and development centre in Bengaluru, India, October 16, 2015. India, which has dominated the generic drugs industry for decades, is falling behind in the race to make copies of complex biotech drugs, which are expected to generate tens of billions of dollars in sales in the coming years. REUTERS/Abhishek N. Chinnappa

Biocon Biologics and Viatris Inc said the U.S. Food and Drug Administration (FDA) had approved Semglee®, a long-acting insulin injection, as the first interchangeable biosimilar product for the treatment of diabetes. This would allow pharmacy level substitution and better affordability and access to Semglee, a biosimilar product, said executive chairperson Kiran Mazumdar-Shaw.

The interchangeable Semglee product, which would allow substitution of Semglee for the reference product, Lantus, at the pharmacy counter, would be introduced before the end of the year. The company would be eligible to have exclusivity for 12 months before the FDA can approve another biosimilar interchangeable to Lantus, said a statement from Biocon Biologics.