Insulin glargine product receives European marketing authorization

Eli Lilly and Company and Boehringer Ingelheim have been granted marketing authorization by the European Commission for their insulin glargine product, indicated for treatment of diabetes in patients older than 2 years, according to a release.

“The marketing authorization for this insulin glargine product in Europe is a significant achievement for the Lilly-Boehringer Diabetes alliance,” Enrique Conterno, president of Lilly Diabetes, said in a press release. “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.”

The product is a basal insulin that contains the same amino acid sequence as the currently marketed insulin glargine product. According to the release, the product will provide long-lasting blood glucose control between meals and at night. It will be marketed as a pre-filled pen and cartridges for a reusable pen.

“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 health care professionals with another option to meet their insulin treatment needs, along with significant expertise and support from the Lilly-Boehringer Ingelheim alliance,” Klaus Dugi, MD, PhD, chief medical officer of Boehringer Ingelheim, said in the release.

The authorization for marketing is based on clinical data, and the application included results from pharmacokinetic and pharmacodynamic studies, as well as phase 3 studies among people with type 1 and type 2 diabetes.

The FDA granted tentative approval for the product, Basaglar, on Aug. 18; however, this new product is not considered a biosimilar in the United States. Abasria in the approved name in Europe but Lilly/Boehringer Ingelheim are working to find a global trade name.