FDA grants tentative approval for Basaglar for Types 1 and 2 Diabetes - Eli Lilly + Boehringer

The FDA granted tentative approval for Basaglar (insulin glargine injection), which is indicated to improve glycaemic 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. The Basaglar approval 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 the FDA cannot give final approval until the end of the 30-month period in mid-2016, unless the court finds in favor of Lilly earlier.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.