Biocon Biologics & Mylan launches Semglee in US for diabetes patients

Biocon's subsidiary Biocon Biologics India Ltd, a fully-integrated pure-play biosimilars company and Mylan announced the launch of Semglee (insulin glargine injection) in the US to expand access for diabetes patients.

Semglee in the vial and pre-filled pen presentations help in controlling high blood sugar in adult and pediatric patients with Type 1 Diabetes and adults with Type 2 Diabetes. It is not recommended for the treatment of diabetic ketoacidosis (DKA). Semglee, which received the final approval from United States Food & Drug Administration (USFDA), has an identical amino acid sequence to Sanofi’s Lantus and has been approved for the same indications.

Notably, the company informed that Semglee is available in vial and pen presentations at a 65 per cent discounted list price, the lowest available for a long-acting insulin glargine on the market. Sanofi’s total IQVIA sales for the 12-month ending June 30, 2020, were nearly US$1.64 billion for Lantus 100 Units/ml vial and approximately US$4.36 billion 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 Mylan-Biocon Biologics collaboration.

Mylan and Biocon Biologics are exclusive partners on a broad portfolio of biosimilars and insulin analogs. Mylan has exclusive  commercialisation rights for insulin glargine in the US, Canada, Australia, New Zealand, the European Union and European Free Trade  Association (EFTA) countries. Biocon Biologics has exclusive rights for Japan and a few emerging markets, as well as co-exclusive commercialisation rights with Mylan in the rest of the world.