CHMP recommends LY 2963016 insulin glargine biosimilar for Types 1 & 2 Diabetes- Eli Lilly + Boehringer

The Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending approval for the investigational compound LY 2963016, a new insulin glargine product, for the treatment of Type 1 and Type 2 Diabetes. The new insulin glargine product from Eli Lilly and Company and Boehringer Ingelheim is the first biosimilar insulin recommended for approval in the European Union (EU).

Lilly/BI's insulin glargine is a basal insulin, which is intended to provide long-lasting blood sugar control between meals and at night, an integral part of glycaemic control. It has the same amino acid sequence as Lantus (insulin glargine) and was filed through the European Medicines Agency's (EMA) biosimilar pathway. As the term is a regulatory designation, Lilly/BI's insulin glargine is considered a biosimilar in some regions, including Europe, but not in others, including the United States.