Eli Lilly, Boehringer Ingelheim Gain Tentative FDA Approval for Insulin Glargine Product

The US Food and Drug Administration (FDA) has granted tentative approval for Basagla (insulin glargine injection), Eli Lilly’s and Boehringer Ingelheim’s basal insulin, which is intended to provide long-lasting blood sugar control in between meals and during the night. Basaglar 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. The drug is part of the diabetes alliance formed between Eli Lilly and Boehringer Ingelheim in 2011.

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. With a tentative approval, the 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 (i.e., the Hatch Waxman 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, a division of the European Medicines Agency. Basaglar is not considered a biosimilar in the US.

The tentative approval in the US is based, in part, on results from Lilly and Boehringer Ingelheim’s clinical development program for their 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 trade name Basaglar was granted provisional approval by the 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 United States for the alliance’s insulin glargine product, which will be announced at a later date.

Source: Eli Lilly

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