First Biosimilar Insulin to Receive CHMP Positive Opinion in the EU

The Committee for Medicinal Products for Human Use (CHMP) today issued a positive opinion recommending approval for the investigational compound LY2963016, 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 (BI) 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 glycemic control.1 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 US.

"The CHMP's recommendation brings us a step closer to providing an important new option for the millions of patients in the EU who need basal insulin to help manage their diabetes," said Enrique Conterno, president, Lilly Diabetes. "This first-ever biosimilar insulin to receive a positive CHMP recommendation underscores Lilly and Boehringer Ingelheim's commitment to providing physicians and patients high-quality diabetes medicines, along with expertise and support tools they need to help manage the disease."

The CHMP's recommendation is based on the companies' non-clinical and clinical development programme, which included pharmacokinetic and pharmacodynamic studies, as well as Phase III studies in patients with type 1 and type 2 diabetes. The European Commission's final decision is expected in approximately 2 months. If approved for marketing authorisation, Lilly/BI's insulin glargine would be the fourth diabetes product in the Lilly-Boehringer Ingelheim Diabetes Alliance to receive regulatory approval in the EU.

Lilly has been manufacturing insulin since 1923, and remains committed to innovation in insulin therapy, introducing many insulin products and delivery devices in the last nine decades. This history gives Lilly extensive expertise, insights and knowledge in the insulin space, enabling it to provide high quality medicine to diabetes patients worldwide.

Reference

1. Inzucchi SE, Bergenstal RM, et al. Management of Hyperglycemia in Type 2 Diabetes: A Patient-Centered Approach. Diabetes Care June 2012 vol. 35 no. 6 1364–1379.