Biocon gets US FDA nod to launch insulin glargine
The product branded as Semglee has an identical amino acid sequence to Sanofis Lantus® and is approved for the same indications. This is the third biologics that Biocon will launch in the US. Semglee was approved as a drug product under the 505(b)(2) NDA pathway and is now deemed a biologic under section 351(a) in accordance with the Biologics Price Competition and Innovation Act in line with other insulin products.