Eli Lilly, Boehringer Ingelheim Receive EU Approval for Biosimilar Insulin Glargine

The European Commission (EC) has granted marketing authorization for Eli Lilly’s and Boehringer Ingelheim’s insulin glargine product, making it the first insulin treatment approved through the European Medicines Agency’s (EMA) biosimilar pathway and the fourth diabetes product approved in the European Union from the diabetes alliance between El Lilly and Boehringer Ingelheim, which the companies formed in 2011.

The alliance’s insulin glargine product is a basal insulin with the same amino acid sequence as Lantus (insulin glargine), Sanofi’s basal insulin product. Lantus is Sanofi’s top-selling drug with 2013 revenues of EUR 5.7 billion ($7.4 billion). The alliance’s insulin glargine is indicated to treat diabetes in adults, adolescents, and children aged two years and above and is intended to provide long-lasting blood sugar control between meals and at night.

Eli Lilly/Boehringer Ingelheim’s insulin glargine product will be available in a pre-filled pen and cartridges for a reusable pen.be manufactured by Lilly, The product’s proprietary name has been approved in Europe as Abasria. The companies are targeting a global trade name for the alliance’s insulin glargine product, which will be announced at a later date.

The marketing authorization for the alliance’s insulin glargine product is based upon a clinical data program, which showed it has similar efficacy and safety compared to the currently marketed insulin glargine product in people with Type 1 and Type 2 diabetes. The application included results from pharmacokinetic and pharmacodynamic studies as well as Phase III studies in patients with Type 1 and Type 2 diabetes.

Source: Eli Lilly

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