Tuesday, August 19, 2014

FDA Tentatively Approves Lilly's New Diabetes Medication

The FDA has granted Eli Lilly “tentative” approval for a diabetes medication akin to Sanofi’s Lantus.  The drug, to be marketed as Basaglar, is a long-lasting insulin injection that helps to control blood-sugar levels and is essentially a knockoff of the Sanofi version.

The new medication, however, won’t reach shelves for at least 30 months as Sanofi has filed a suit claiming patent infringement.  The drug could hit the market earlier if the court rules in favor of Eli Lilly but is in a holding pattern until then.  Lantus is scheduled to come off of patent February of next year.  This news comes months after Merck divulged plans to develop its own knockoff of the diabetes medication. 

Basaglar has the same amino acid sequence as Sanofi’s drug but for technical reasons is not considered a biosimilar—although for all intents and purposes, it is one.  By European standards, the drug does actually fall under the biosimilar classification and goes by the name Abasria.    

Said Christophe Arbet-Engels, Vice President, Metabolic-clinical Development and Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc., "Because of the combined diabetes, development and commercialization experience of Lilly and Boehringer Ingelheim, we are confident that Basaglar, upon final approval, will become a valuable treatment choice for people who need a basal insulin to manage their type 1 or type 2 diabetes."

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