Pharmaceutical company Mylan NV (NASDAQ:MYL) and Biocon Ltd (BSE:532523) (NSE:BIOCON) on Thursday jointly announced the US Food and Drug Administration's (FDA) approval of the New Drug Application (NDA) for Semglee (insulin glargine injection), in vial and pre-filled pen presentations, to control high blood sugar in adults with type 2 diabetes and adult and paediatric patients with type 1 diabetes.

Co-developed by the partnership, 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.

Semglee has an identical amino acid sequence to Sanofi's Lantus and is approved for the same indications.

The FDA approval was based on the partnership's comprehensive analytical, preclinical and clinical programme, including the INSTRIDE studies, which confirmed the PK/PD, efficacy, safety and immunogenicity of Semglee in comparison to Lantus in patients with type 1 and type 2 diabetes.

For the 12 months ending 30 April 2020, Sanofi's total IQVIA sales were approximately USD1.68bn for Lantus 100 units/ml Vial and approximately USD4.33bn for Lantus SoloSTAR Pen. Mylan and Biocon Biologic's insulin glargine has received regulatory approval in more than 45 countries around the world and is the third product approved by FDA through the partners' collaboration.