USFDA okays Biocon insulin Semglee as first interchangeable biosimilar drug

Analysts expect additional revenues of 8 to 15 per cent for Biocon, with no competition in sight

The US drug regulator has approved Biocon’s Semglee, the first interchangeable biosimilar insulin product, to treat diabetes patients. This means that Semglee can be substituted for its reference drug – Sanofi’s Lantus – by a pharmacist in the US without any intervention of the prescriber. Lantus is a long-acting insulin glargine.

The move will empower patients by “helping to increase access to safe, effective and high-quality medications at potentially lower cost”, the US Food and Drug Administration (USFDA) said in a statement. Semglee will be manufactured by Biocon Biologics, a subsidiary of the Bengaluru-headquartered firm, and marketed by its partner