Biocon rose 1.07% to Rs 391.05 after the company and Mylan announced the receipt of U.S. Food and Drug Administration's (FDA) approval for Semglee (insulin glargine injection) in vial and pre-filled pen presentations.
The drug is used 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.
Sanofi's total IQVIA sales for the 12 months ended 30 April 2020 were approximately $1.68 billion for Lantus 100 Units/mL Vial and approximately $4.33 billion for Lantus SoloSTAR Pen.
Mylan and Biocon Biologics co-developed insulin glargine (Semglee) has received regulatory approval in more than 45 countries around the world and is the third product approved by FDA through the Mylan-Biocon Biologics collaboration.
The two firms are exclusive partners on a broad portfolio of biosimilars and insulin analogs. Mylan has exclusive commercialization rights for insulin glargine in the U.S., Canada, Australia, New Zealand, the European Union and European Free Trade Association countries. Biocon Biologics, a subsidiary of Biocon, has exclusive rights for Japan and a few emerging markets, and co-exclusive commercialization rights with Mylan in the rest of the world.
Biocon is an innovation-led global biopharmaceuticals company. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets as well as generic formulations in the US and Europe.
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