Biocon and Mylan N.V. have received an approval from the US Food and Drug Administration (USFDA) for the New Drug Application (NDA) for Semglee (insulin glargine injection), in vial and prefilled pen presentations, to control high blood sugar in adults with type 2 diabetes and adult and pediatric patients with type 1 diabetes. Semglee has an identical amino acid sequence to Sanofi’s Lantus and is approved for the same indications.
Semglee, codeveloped by Mylan and Biocon Biologics, 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.
Biocon is India’s largest and Asia’s leading Biotechnology Company with a strategic focus on biopharmaceuticals and research services. It is a fully integrated, innovationdriven biopharma enterprise offering affordable solutions for chronic diseases to patient's worldwide.
