Eli Lilly & Co. won European backing for a biosimilar version of Sanofi’s Lantus insulin, paving the way for the first copycat of the French drugmaker’s top-selling medicine.
Lilly’s Abasria insulin was recommended by the European Medicines Agency’s Committee for Medicinal Products for Human Use for the treatment of diabetes, the agency said in a statement today. The European Commission, the EU’s executive arm, usually follows the panel’s recommendation.
Lantus, which garnered Paris-based Sanofi 5.7 billion euros ($7.8 billion) in sales in 2013, loses patent protection in Europe in May next year. The U.S. patent on Lantus expires in February, but biosimilar competition there may be delayed after Sanofi in January said it was suing Indianapolis-based Lilly over its plans to introduce a version in the U.S.
Sales of the drug in Europe were less than 15 percent of the total in 2013, because the price of the drug is far lower than in the U.S., which accounted for almost two-thirds of total Lantus sales, said Mark Clark, an analyst at Deutsche Bank AG in London. That may limit the erosion of Lantus sales in Europe, he said.
“The imperative to switch to the cheaper version is probably less in Europe,” Clark said by phone today. “It’s not much of a needle-mover, this news.”
Lilly fell 0.2 percent to $62.94 as of 9:32 a.m. in New York, while Sanofi rose 0.1 percent to 77.74 euros at 3:32 p.m. in Paris.
Biosimilars are lower-cost versions of complex drugs made from living organisms, unlike generic drugs which are exact copies of simpler chemical compounds. Abasria, also known as insulin glargine, has the same amino acid sequence as Lantus, Lilly said in a statement today, and has been shown in trials that it has comparable quality, safety and efficacy to Sanofi’s drug.
Lilly has made an aggressive push to expand its diabetes products, with drugs in every class of therapy for what it calls a full suite of offerings for doctors, health insurers and governments.
The company said last month a separate once-daily insulin injection called Peglispro was better than Lantus in controlling patients’ blood sugar, a measure of how well a patients’ diabetes is under control. Lilly has said it will file for U.S. approval to sell that drug in the first quarter of next year.
“While the development of insulin glargine biosimilars will be important for increasing treatment access, Lantus, with its well-established efficacy and safety profile and strong heritage, continues to offer a competitive benefit being the most studied basal insulin,” Jack Cox, a Sanofi spokesman, said by e-mail.
Lilly developed Abasria with Ingelheim, Germany-based Boehringer Ingelheim GmbH.