USFDA approves Biocon & Mylans Semglee

United States Food and Drug Administration (USFDA) granted approval to Semglee, an insulin glargine injection co-developed by Biocon Limited and Mylan N.V, which will be in vial and pre-filled pen presentations form used to keep in check high blood sugar in adults with type 2 diabetes, and adult and pediatric patients with type 1 diabetes.

Relative to Sanofi’s Lantus, Semglee has an identical amino acid sequence and is approved for the same indications. For the 12 months ending April 30, 2020, Sanofi’s total IQVIA sales were approximately US$ 1.68 billion for Lantus 100 Units/mL Vial and approximately US$ 4.33 billion for Lantus SoloSTAR Pen.

Semglee was authorized 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. The approval for Semglee was based on a comprehensive analytical, preclinical and clinical program (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.

Mylan and Biocon Biologics insulin glargine has received regulatory approval in over 45 countries around the world and is the third product approved by USFDA through the Mylan-Biocon Biologics collaboration.

In 2018, Pegfilgrastim biosimilar was rolled out in USA which is used to treat infection in patients undergoing chemotherapy, whereas in 2019, Trastuzumab biosimilar was launched in USA treating breast cancer and gastric cancer. Both these products are co-developed by Myan and Biocon Biologics.

Biocon’s stock rallied 2.4 per cent to Rs 396 from its previous close of Rs 386.90 on BSE, in the early morning session on Friday.