The European Medicines Agency (EMA) has accepted to review Eli Lilly and Company and Boehringer Ingelheim's marketing authorisation application (MAA) for LY2963016, an investigational basal (long-acting) insulin for the treatment of type 1 and type 2 diabetes. LY2963016 is a new insulin glargine product and has been filed through the EMA's biosimilar pathway.

Lilly and Boehringer Ingelheim have studied LY2963016 in a comprehensive clinical development program in order to meet the highest standards of safety, efficacy and quality. In addition to pharmacokinetic and pharmacodynamic studies, phase III studies in patients with type 1 and type 2 diabetes have been conducted and results submitted, using currently marketed insulin glargine as the active comparator.

"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," said Gwen Krivi, vice president, Lilly Diabetes product development. "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."

Type 2 diabetes is the most common type, accounting for an estimated 90 per cent of all diabetes cases. Diabetes is a chronic disease that occurs when the body either does not properly produce, or use, the hormone insulin.

In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in the field of diabetes that centres on three compounds representing several of the largest treatment classes. This alliance leverages the companies' strengths as two of the world's leading pharmaceutical companies, combining Boehringer Ingelheim's solid track record of research-driven innovation and Lilly's innovative research, experience, and pioneering history in diabetes. By joining forces, the companies demonstrate commitment in the care of patients with diabetes and stand together to focus on patient needs.

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.

Lilly, a leading innovation driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organisations.