European Commission grants Lilly and Boehringer Ingelheim's insulin glargine product marketing authorisation in Europe

EMA

The European Commission (EC) granted marketing authorisation for Eli Lilly and Company and Boehringer Ingelheim’s insulin glargine product, indicated to treat diabetes in adults, adolescents and children aged 2 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. It received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) on June 26, 2014.

"The marketing authorisation for this insulin glargine product in Europe is a significant achievement for the Lilly-Boehringer Ingelheim Alliance. We believe that insulin glargine will continue to be widely used for many years, and Lilly and Boehringer Ingelheim are committed to addressing the needs of people living with diabetes and providing support beyond the medicine," said Enrique Conterno, president, Lilly Diabetes.

The Alliance's 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.

For more details, go to: http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2014/10_september_2014_insulin_glargine.html

Michael Wonder

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Michael Wonder

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