Credit: Reuters/Ralph Orlowski
A packet of diabetes drug Lantus SoloStar passes along the production line at a manufacturing site of French drugmaker Sanofi in Frankfurt June 5, 2013.
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)
