Biocon jumps on launching Semglee in US

Biocon jumped 5.30% to Rs 396.35 announced the US launch of Semglee in vial and pre-filled pen presentations for patients living with diabetes.

Semglee (insulin glargine injection), which received final approval from the US Food and Drug Administration (FDA), helps in controling 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.

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 ending 30 June 2020 were approximately $1.64 billion for Lantus 100 Units/mL Vial and approximately $4.36 billion for Lantus SoloSTAR Pen.

 

To encourage broad patient access to this important medicine, Mylan is offering Semglee at a wholesale acquisition cost (WAC) of $147.98 per package of five 3ml pens and $98.65 per 10ml vial, representing the lowest WAC for any long-acting insulin glargine on the market. The list price of Semglee pen is equivalent to the Lantus launch price in 2007, and the Semglee vial is listed at Lantus's 2010 pricing. Eligible patients may also qualify for patient assistance and/or a co-pay card, similar to other medications in this class. Additionally, Mylan has submitted to 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.

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.

Biocon is a fully integrated, innovation-led global biopharmaceuticals company. The biopharmaceuticals company's consolidated net profit fell 28% to Rs 149 crore on a 15% rise in revenue from operations to Rs 1671 crore in Q1 FY21 over Q1 FY20.

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