Separately, Sanofi confirmed that it has reached a settlement agreement with Eli Lilly and Company, which addresses patents on Sanofi’s Lantus SoloSTAR (insulin glargine).
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The settlement relates to patents covering Sanofi’s Lantus SoloSTAR formulation of the basal insulin, a pen injector version which accounts for nearly two-thirds of Lantus $7bn total sales.
The US Food and Drug Administration tentatively approved Basaglar in August 2014.
Lantus is Sanofi’s best-selling product, with more than $7 billion in 2014 sales, so it’s no surprise that the company has been fighting back against Lilly and Boehringer Ingelheim’s biosimilar version.
Lilly and Boehringer already sell Basaglar in the Kwikpen in several European countries.
In addition, as part of the settlement, Lilly will pay Sanofi royalties in exchange for a license for certain patents.
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Basaglar was granted tentative approval by the FDA previous year but its launch was delayed by a legal challenge for Sanofi which alleged infringement of four patents on Lantus. “Sanofi and Lilly accepted end that in fact court action and cut off comparable gainsays world-wide”. Lilly also sells the new diabetes pill Jardiance, recently shown in a study to prevent fatal heart attacks and strokes. Type 1 diabetes, often called insulin-dependent diabetes, typically is diagnosed in childhood or adolescence, while Type 2 diabetes typically strikes in middle age.
