Eli Lilly, Boehringer Ingelheim Receive EU Approval for Biosimilar Insulin GlargineBy
The European Commission (EC) has granted marketing authorization for
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