The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) 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), according to the companies.

Eli Lilly/Boehringer Ingelheim’s insulin glargine is a basal insulin, which is intended to provide long-lasting blood sugar control between meals and at night. It has the same amino acid sequence as Sanofi’s Lantus (insulin glargine) and was filed through the EMA’s 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, in a company release. “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 authorization, Lilly/BI’s insulin glargine would be the fourth diabetes product in the Eli Lilly-Boehringer Ingelheim Diabetes Alliance to receive regulatory approval in the EU. Boehringer Ingelheim and Eli Lilly and Company formed an alliance in diabetes in January 2011.

Source: Eli Lilly