EU approval for Boehringer and Lilly's insulin glargine biosimilar

The European Commission granted marketing authorization for US drug major Eli Lilly (NYSE: LLY) and family-owned German pharma company 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 European Union from the Lilly-Boehringer Ingelheim Alliance. It received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) on June 26. The US Food and Drug Administration granted tentative approval for Basaglar (insulin glargine injection) last month (The Pharma Letter August 19).

"The marketing authorization 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.