(Reuters) - Eli Lilly and Co and Boehringer Ingelheim said on Wednesday that the European Commission approved their copycat version of Sanofi SA’s blockbuster insulin, Lantus.
The treatment, to be manufactured by Lilly, comprises a type of basal insulin, intended to provide long-lasting blood sugar control between meals and at night.
The therapy received a positive recommendation from the European Medicine Agency in June.
The product will be made available in a pre-filled pen and cartridges for a reusable pen, the companies said.
The approval is for a so-called biosimilar version of Lantus, which generates annual sales of about $8 billion. Biosimilar medicines are copies of biotech drugs that promise to cut the cost of treatment.
Lantus currently dominates the market, out-selling a rival treatment Levemir from Denmark’s Novo Nordisk.
Europe accounted for 14 percent of Lantus’ global sales last year.
The U.S. Food and Drug Administration granted Lilly-Boehringer’s drug tentative approval in August, under the provisional trade name Basaglar, but it is not considered a biosimilar in the region.
Reporting by Natalie Grover in Bangalore; Editing by Sriraj Kalluvila