Lilly and Boehringer Ingelheim biosimilar submitted for EU approval

Lilly and Boehringer Ingelheim have announced that their new biosimilar diabetes therapy LY2963016 has been accepted for review by the European Medicines Agency (EMA).

The companies' marketing authorisation application, which was filed through the EMA's biosimilar pathway, has now been accepted, bringing the manufacturers a step closer to delivering this new insulin glargine product to patients.

Phase III studies have been carried out in patients with type 1 and type 2 diabetes to show that LY2963016 can offer similar benefits to currently marketed insulin glargine offerings.

Dr Gwen Krivi, vice-president for product development at Lilly Diabetes, 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."

This comes as part of a long-running diabetes alliance between Lilly and Boehringer Ingelheim that commenced in January 2011.

Last month, the companies reported clinical trial data for the diabetes therapy linagliptin showing that the use of this drug does not significantly increase patients' risk of cardiovascular events.