European Commission Grants Lilly and Boehringer Ingelheim's Insulin Glargine Product Marketing in EU

September 12, 2014
BioPharm International Editors

European Commission granted the first biosimilar insulin to receive regulatory approval in Europe.

The European Commission (EC) granted marketing authorization for Eli Lilly and Company and Boehringer Ingelheim's insulin glargine product, indicated to treat diabetes in adults, adolescents, and children aged two years and above. Lilly/Boehringer Ingelheim's insulin glargine product is the first insulin treatment approved through the European Medicines Agency's biosimilar pathway and the fourth diabetes product approved in the EU from the Lilly-Boehringer Ingelheim Alliance.

The insulin glargine product is a basal insulin with the same amino acid sequence as Lantus (insulin glargine) and is intended to provide long-lasting blood sugar control between meals and at night. Lilly/Boehringer Ingelheim's insulin glargine product will be available in a pre-filled pen and cartridges for a reusable pen.

The marketing authorization for the Alliance's insulin glargine product is based upon a comprehensive 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.

While 'Abasria' is an approved name in Europe, it's not necessarily approved in other regions. Lilly and Boehringer Ingelheim are targeting a global trade name for the Alliance's insulin glargine product, which will be announced at a later date.

Lilly/Boehringer Ingelheim's insulin glargine product will be manufactured by Lilly, which has been manufacturing insulin since 1923.

Source: Eli Lilly and Company

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