The European Medicines Agency (EMA) has accepted Eli Lilly and Company and Boehringer Ingelheim's marketing authorisation application (MAA) for a new insulin glargine product, LY2963016, for review.
The application has been filed through the EMA's biosimilar pathway for the investigational basal (long-acting) insulin to treat type 1 and type 2 diabetes.
Lilly Diabetes product development vice president Dr Gwen Krivi said, "Long-acting insulin is a mainstay treatment for many people with diabetes, and we anticipate that insulin glargine will continue to be widely used for many years to come."
"We are pleased that the EMA's acceptance of our application brings us closer to offering a new insulin glargine product to clinicians and their patients, coupled with the expertise they expect from Lilly and Boehringer Ingelheim."
LY2963016 was evaluated for safety, efficacy and quality in pharmacokinetic and pharmacodynamic studies, Phase III studies in patients with type 1 and type 2 diabetes.
Results of the studies have been submitted, using currently marketed insulin glargine as the active comparator.
Lilly and Boehringer Ingelheim announced partnership in the field of diabetes in January 2011, which focuses on three compounds representing several of the largest treatment classes.