Mylan N.V. (NASDAQ:MYL) and Biocon Biologics India, a subsidiary of Biocon Ltd. (OTC:BCNQY), announce the U.S. launch of Semglee (insulin glargine injection) in vial and pre-filled pen to help control 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.
FDA approved Semglee has an identical amino acid sequence to Sanofi’s Lantus.
Mylan is offering Semglee at a wholesale acquisition cost (WAC) of $147.98/package of five 3ml pens and $98.65 per 10ml vial, representing the lowest WAC for any long-acting insulin glargine on the market.
Additionally, Mylan has submitted to the FDA all necessary documentation to request approval of Semglee as a biosimilar to Lantus under the 351(k) pathway and remains confident in seeking an interchangeability designation.
Sanofi’s total IQVIA sales for the 12 months ending June 30 were ~$1.64B for Lantus 100 Units/mL Vial and ~$4.36B for Lantus SoloSTAR Pen.
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