The Committee for Medicinal Products for Human Use (CHMP) 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 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. 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.
"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 program, 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 two 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.
In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in diabetes that centers on compounds representing several of the largest diabetes treatment classes. The alliance leverages the strengths of two of the world's leading pharmaceutical companies. By joining forces, the companies demonstrate commitment in the care of patients with diabetes and stand together to focus on patient needs.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest US subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.