
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
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