News Feature | September 11, 2014

EC Approves Lilly And BI's Insulin Glargine Product

By Estel Grace Masangkay

Eli Lilly & Co. together with its partner Boehringer Ingelheim announced that the European Commission (EC) has granted marketing authorization to the companies’ insulin glargine product for diabetes in the EU. The product is the first biosimilar insulin to be approved through the European Medicines Agency's (EMA) biosimilar pathway.

The collaborators’ insulin glargine product is a basal insulin that has the same amino acid sequence as Sanofi’s insulin glargine Lantus. Lilly and BI’s product will be released in a pre-filled pen and cartridge for a reusable pen for the maintenance of blood sugar control between meals and during nighttime. Currently known as ‘Abasria’ in the EU, the product will be christened with a new global trade name in the future.

“Basal insulin is an important mainstay of treatment for people with type 1 and type 2 diabetes, and we're pleased that Lilly/Boehringer Ingelheim's insulin glargine product will provide healthcare professionals and patients with another option to meet their insulin treatment needs,” said Professor Klaus Dugi, CMO of Boehringer Ingelheim.

The approval was supported by positive efficacy and safety data which showed the product was not inferior to Lantus in Type 1 and Type 2 diabetes. The alliance’s Marketing Authorization Application (MAA) also included data from pharmacokinetic and pharmacodynamic studies, as well as results from Phase III trials in diabetes patients. In June, the EMA Committee for Medicinal Products for Human Use (CHMP) also recommended the companies’ insulin glargine.

“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,” said Enrique Conterno, president of Lilly Diabetes.

In the U.S., the Food and Drug Administration (FDA) awarded tentative approval last month to Lilly and BI’s insulin glargine injection under the brand name Basaglar.