EMA Advisory Panel Recommends First Biosimilar Insulin

Miriam E. Tucker

June 27, 2014

The European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) has recommended approval of a biosimilar version of insulin glargine (Abasria, Eli Lilly/Boehringer Ingelheim) for the treatment of type 1 or type 2 diabetes in adults and children as young as 2 years of age.

Abasria is a basal insulin with the same amino-acid sequence as the familiar Lantus (insulin glargine) developed by Sanofi, which has been available in the European Union since June 9, 2000. "Studies have shown Abasria to have a comparable quality, safety, and efficacy profile to Lantus (insulin glargine)," according to a CHMP statement.

Filed through the EMA's biosimilar pathway, Lilly/Boehringer Ingelheim's insulin glargine is the first biosimilar insulin recommended for approval in the European Union. The product is considered a biosimilar in some regions, including Europe, but not in others, including the United States.

According to the EMA, "Biosimilars can be authorized for use only once the period of data exclusivity on the original 'reference' biological medicine has expired. In general, this means that the biological reference medicine must have been authorized for at least 10 years before a similar biological medicine can be made available by another company."

The CHMP's recommendation for Lilly/ Boehringer Ingelheim's insulin glargine is based on the companies' nonclinical and clinical development program, which included pharmacokinetic and pharmacodynamic studies, as well as phase 3 studies in patients with type 1 and type 2 diabetes.

The European Commission's final decision is expected in approximately 2 months. A pharmacovigilance plan for Abasria will be implemented as part of the marketing authorization.


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