Lilly, Boehringer Ingelheim's Biosimilar Insulin Receives CHMP Recommendation
Eli Lilly and collaborator Boehringer Ingelheim announced that the investigational compound LY2963016 has received positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) as an insulin glargine product for the treatment of Type 1 and 2 diabetes.
LY2963016 is a basal insulin intended to provide long lasting glycemic control between meals and at night. It contains the same amino acid sequence as insulin glargine lantus and was filed through the biosimilar pathway of European Medicines Agency’s (EMA). The compound is the first biosimilar insulin recommended by CHMP in the EU.
The positive CHMP recommendation for the investigational compound LY2963016 is supported by both non-clinical and clinical development program. This included pharmacokinetic and pharmacodynamic studies as well as Phase III trials. The companies said the European Commission’s final decision is expected in about two months.
Enrique Conterno, president of Lilly Diabetes, said, “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. 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.”
Approximately 382 million people around the world are afflicted with type 1 or type 2 diabetes. Type 2 diabetes is the most common and accounts for around 85 to 95 percent of all cases.
Lilly and Boehringer Ingelheim first announced their alliance in diabetes in January 2011, when the companies agreed to work on developing diabetes compounds. If approved, LY2963016 would be the fourth diabetes product in the Lilly-Boehringer Ingelheim Diabetes Alliance to secure regulatory approval in the EU.