Developed by Eli Lilly and Boehringer Ingelheim, the new insulin glargine product is the first biosimilar insulin recommended for approval in the European Union (EU).
The new 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.
The product has the same amino acid sequence as Lantus (insulin glargine) and was filed through the EMA’s biosimilar pathway.
Lilly Diabetes president Enrique Conterno said the CHMP’s recommendation brings the company 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," Conterno said.
The CHMP positive opinion is based on the companies’ non-clinical and clinical development program, which included pharmacokinetic and pharmacodynamic studies, as well as Phase III trials in patients with type 1 and type 2 diabetes.
The company expects to get final decision from the European Commission in about two months and if approved, the insulin glargine would be the fourth diabetes product in the Lilly-Boehringer Ingelheim Diabetes Alliance to receive regulatory approval in the EU.