EU approves Abasria for Diabetes-Eli Lilly/Boehringer

The European Commission (EC) granted marketing authorisation for Abasria (insulin glargine-biosimilar), from Eli Lilly and Boehringer, indicated to treat Diabetes in adults, adolescents and children aged 2 years and above. Abasria 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. Authorisation s based upon a comprehensive clinical data programme, which showed it has similar efficacy and safety compared to the currently marketed insulin glargine product in people with Type 1 and type 2 Diabetes. The application included results from pharmacokinetic and pharmacodynamic studies, as well as Phase III studies in patients with Type 1 and 2 Diabetes.