The FDA granted tentative approval to Eli Lilly and Boehringer Ingelheim's Basaglar (insulin glargine) for use in patients with type 1 and 2 diabetes, the companies announced. Eli Lilly and Boehringer Ingelheim noted that the product, which was filed through the agency's 505(b)(2) regulatory pathway, has the same amino acid sequence as Sanofi's Lantus and is intended to be used with the pre-filled KwikPen dosing device.
Eli Lilly and Boehringer Ingelheim said that while "the FDA has determined that Basaglar meets all of the regulatory requirements for approval," the therapy "is subject to an automatic stay of up to 30 months as a result of litigation filed by Sanofi." The lawsuit, filed earlier this year in District Court in Delaware, alleges that Basaglar infringes four of Sanofi's patents. Eli Lilly and Boehringer Ingelheim indicated that "the 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."
Basaglar, previously known as LY2963016, has been tentatively approved 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. The companies said the decision is partly based on results from pharmacokinetic and pharmacodynamics studies, as well as Phase III trials in people with type 1 and 2 diabetes. "We believe insulin glargine will continue to be used widely for many years," remarked Enrique Conterno, president of Eli Lilly's diabetes unit.
In June, the European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion recommending approval of Eli Lilly and Boehringer Ingelheim's insulin glargine product. If authorised in Europe, the therapy will be sold as Abasria, where it is considered a biosimilar version of Lantus.
For related analysis, read ViewPoints: Shake-up or false dawns? - biosimilar Lantus and inhaled insulin Afrezza approved, and for more information on the biosimilar market, see The Future of Biosimilars: Mapping Critical Uncertainties and the Impact of Future Events.
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