The first insulin biosimilar has been approved in Europe

The European Commission granted marketing authorisation to Eli Lilly and Company and Boehringer Ingelheim for the first insulin biosimilar glargine product. It is  indicated to treat diabetes in adults, adolescents and children aged 2 years and above. The collaboration between the two companies is bearing fruit, it is the first-ever version of this class.  It received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP).

“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 called “Abasria” is a basal insulin with the same amino acid sequence as Lantus® (insulin glargine by Sanofi) and is intended to provide long-lasting blood sugar control between meals and at night. It is called a biosimilar, which are lower-cost versions of complex drugs made from living organisms, unlike generic drugs which are exact copies of simpler chemical compounds. Lilly/Boehringer Ingelheim’s insulin glargine product will be available in a pre-filled pen and cartridges for a reusable pen. The autorisation of the product, is based on a clinical programme which showed compared safety and efficacy with the currently marketed insulin glargine product in people with type 1 and type 2 diabetes. This included results from pharmacokinetic and pharmacodynamic studies, as well as Phase III studies in patients with type 1 and type 2 diabetes. For the moment, Abasria can’t be sold in the USA because Sanofi has filed a lawsuit against Boehringer and Lilly claiming patent infringement. Sanofi tries to protect his huge market since Lantus generated over $7bn revenues during 2013.

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