Biocon gets US FDA nod to launch insulin glargine

The product branded as Semglee has an identical amino acid sequence to Sanofi’s 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.

from Healthcare/Biotech-Industry-Economic Times https://ift.tt/3fsQqB5
via IFTTT

0 comments:

Post a Comment