The European Commission (EC) granted marketing authorisation for Eli Lilly and Company (NYSE: LLY) 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 Diabetes 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 the currently marketed insulin glargine product 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.
"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, along with significant expertise and support from the Lilly-Boehringer Ingelheim alliance," said Professor Klaus Dugi, Chief Medical Officer, Boehringer Ingelheim.
The marketing authorisation for the alliance's insulin glargine product is based upon a comprehensive clinical data program. 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. In the U.S., the Food and Drug Administration granted tentative approval for Lilly/Boehringer Ingelheim's insulin glargine product on August 18, 2014, with the provisional trade name 'Basaglar.' The product is not considered a biosimilar in the United States.
Lilly/Boehringer Ingelheim's insulin glargine product will be manufactured by Lilly, which has been manufacturing insulin since 1923. This history gives Lilly extensive expertise, insights and knowledge in the insulin space, enabling it to provide high quality medicines to diabetes patients worldwide.
Eli Lilly and Company; Boehringer Ingelheim