Eli Lilly and Company and Boehringer Ingelheim announce regulatory submission for new insulin glargine biosimilar product

Eli Lilly and Company (NYSE: LLY) and Boehringer Ingelheim today announced that the companies’ marketing authorisation application (MAA) for LY2963016, an investigational basal (long-acting) insulin for the treatment of type 1 and type 2 diabetes, has been accepted for review by the European Medicines Agency (EMA). 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, Ph.D., 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.”

About Diabetes

An estimated 371 million people worldwide have type 1 and type 2 diabetes.1 Type 2 diabetes is the most common type, accounting for an estimated 90 percent of all diabetes cases.2 Diabetes is a chronic disease that occurs when the body either does not properly produce, or use, the hormone insulin.3

Boehringer Ingelheim and Eli Lilly and Company

In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in the field of diabetes that centers 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. Find out more about the alliance at www.boehringer-ingelheim.com or www.lilly.com.

References

1. International Diabetes Federation. IDF Diabetes Atlas Poster (2012 Update – 5th Edition). 2012.
2. World Health Organization. 2009. Available from www.who.int/mediacentre/factsheets/fs312/en/print.html Accessted February 2013
3. International Diabetes Federation. What is Diabetes IDF Website – IDF DIABETES ATLAS 5th edition. 2012.