Lilly, Boehringer win tentative FDA approval for Sanofi diabetes biosimilar
- Basaglar is a biosimilar version of Sanofi’s Lantus (insulin glargine), which is used to treat adults with type 2 diabetes and pediatric patients with type 1 diabetes.
- The same Lantus biosimilar was approved in the EU in June. It is marketed as Abasria.
- Basaglar is co-marketed by Eli Lilly and Boehringer Ingelheim (BI). The companies are currently embroiled in a contentious patent infringement lawsuit with Sanofi over the biosimilar.
An increasing number of approved biosimilars is bound to be a game changer for U.S. pharmaceuticals. The Generic Pharmaceutical Association (GPhA) calls biologics “the future of medicine,” noting that by 2016, eight of the top 10 drugs on the market could very well be biologics.
The FDA is in the process of clarifying the approval pathway for biosimilars. In the case of a drug as important and widely used as Lantus -- which had $7.6 billion in revenues in 2013 -- approving an alternative treatment option is crucial and will save a great deal of money going forward.
Because of the lawsuit, Basaglar is automatically subject to a 30-month stay unless a ruling is made in that time.
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