Diabetes drug Basaglar receives tentative FDA approval
The FDA has granted tentative approval for Basaglar (insulin glargine injection), produced by Eli Lilly and Boehringer Ingelheim's (BI) diabetes alliance, following litigation filed by Sanofi claiming patent infringement.
The terms of the tentative approval mean the drug – categorised as a biosimilar in Europe but not in the US – is subject to an automatic stay of up to 30 months.
Basaglar is indicated to improve glycaemic control in adults with type 2 diabetes and in combination with mealtime insulin in adults and paediatric patients with type 1 diabetes. It has the same amino acid sequence as Sanofi's blockbuster Lantus and was tentatively approved for use with KwikPen, a pre-filled dosing device.
Lantus goes off patent from February 2015 and several biosimilars are set to benefit as a result in the lucrative diabetes drug market. Sanofi is hitting back with its new insulin glargine formulation Toujeo (U300), which was filed with the European Medicines Agency in June and the FDA in July, which it hopes will continue the company's dominance in the field.
Under the Drug Price Competition and Patent Term Restoration Act ("Hatch Waxman"), the FDA cannot give final approval to Basaglar until the end of the 30-month period in mid-2016, unless the court finds in favour of Lilly earlier, which buys time for Sanofi.
The tentative approval is based, in part, on results from pharmacokinetic and pharmacodynamics studies, as well as phase III studies in people with type 1 and type 2 diabetes.
The Basaglar NDA 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.
The drug was approved as a biosimilar in Europe in June under the name Abasria.
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