The U.S. Food and Drug Administration on Wednesday granted final approval to Eli Lilly’s diabetes treatment Basaglar, a copy of Sanofi AG’s blockbuster insulin Lantus.
In a press release announcing the decision, the U.S. agency said the drug was the first insulin product approved after it was shown to be similar enough to Sanofi’s previously approved Lantus.
The approval for the long-acting human insulin analog, manufactured by Eli Lilly and Company in Indianapolis, Indiana, came on Dec. 16. According to the FDA, the drug plays an important role in the treatment of both type 1 and type 2 diabetes and its approval is expected to expand the availability of treatment options for patients and healthcare professionals.
Basaglar was tentatively approved in the U.S. in August 2014, with final approval pending the resolution of the patent litigation. Per the settlement agreement with Sanofi, the drug will be available in the U.S. starting on December 15, 2016.
Basaglar is an injection known also as insulin glargine, which is used to treat type 1 and type 2 diabetes.
Lantus racked up more than $5 billion in global sales for the first nine months of the year, but Basaglar’s availability outside the U.S. is already causing Lantus sales declines.
Deutsche Bank estimates Basaglar will generate about $622 million in sales in 2020. Lilly says U.S. pricing hasn’t been set yet.
According to the Centers for Disease Control and Prevention, about 21 million people in the U.S. have been diagnosed with diabetes.