FDA Grants Tentative Approval for Lilly and Boehringer Ingelheim's Basaglar

FDA has granted tentative approval for Basaglar (insulin glargine injection), which is indicated to improve glycemic control in adults with type 2 diabetes and in combination with mealtime insulin in adults and pediatric patients with type 1 diabetes. Basaglar is not recommended for the treatment of diabetic ketoacidosis. Basaglar is Eli Lilly and Company and Boehringer Ingelheim's basal insulin, which is intended to provide long-lasting blood sugar control in between meals and during the night.

Basaglar has the same amino acid sequence as the currently marketed insulin glargine product and was tentatively approved for use with KwikPen, a pre-filled dosing device. Basaglar is contraindicated during episodes of hypoglycemia and in patients with hypersensitivity to insulin glargine or one of its other ingredients.

With a tentative approval, FDA has determined that Basaglar meets all of the regulatory requirements for approval, but it is subject to an automatic stay of up to 30 months as a result of litigation filed by Sanofi, claiming patent infringement. Under the Drug Price Competition and Patent Term Restoration Act (Hatch Waxman), FDA cannot give final approval until the end of the 30-month period in mid-2016, unless the court finds in favour of Lilly earlier.

"The tentative approval for Basaglar is another step toward providing an important option for people with diabetes in the US who need basal insulin treatment," said Enrique Conterno, president, Lilly Diabetes. "We believe insulin glargine will continue to be used widely for many years, and Lilly and Boehringer Ingelheim are committed to addressing the needs of people living with diabetes and providing support beyond the medicine."

The tentative approval is based, in part, on results from Lilly and Boehringer Ingelheim's extensive clinical development programme for the alliance's insulin glargine product. The submission included results from pharmacokinetic and pharmacodynamics studies, as well as Phase III studies in people with type 1 and type 2 diabetes.

The Basaglar new drug application was filed through the FDA's 505(b)(2) regulatory pathway, which allows the agency to consider the efficacy and safety of the existing insulin glargine product. Lilly-Boehringer Ingelheim's insulin glargine product is considered a biosimilar in other regions such as Europe, where it recently received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP), a division of the European Medicines Agency. Basaglar is not considered a biosimilar in the United States.

"Because of the combined diabetes, development and commercialization experience of Lilly and Boehringer Ingelheim, we are confident that Basaglar, upon final approval, will become a valuable treatment choice for people who need a basal insulin to manage their type 1 or type 2 diabetes," said Christophe Arbet-Engels, MD, PhD, vice president, metabolic-clinical development and medical affairs, Boehringer Ingelheim Pharmaceuticals, Inc.

The trade name 'Basaglar' was granted provisional approval by FDA and will be used in the US market once the product is made available to patients. While 'Abasria' is an approved name in Europe, it's not necessarily approved in other regions. Lilly and Boehringer Ingelheim are targeting a global trade name outside of the US for the alliance's insulin glargine product, which will be announced at a later date.