Eli Lilly, Boehringer Ingelheim Receive EU Advisory Committee OK for a Biosimilar InsulinBy
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/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
“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
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.
Source: Eli Lilly