Eli Lilly wins European backing for generic version of Sanofi’s Lantus insulin

Ruling paves way for the first copycat of the French drugmaker’s top-selling medicine

Eli Lilly has won European backing for a generic 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 in sales in 2013, loses patent protection in Europe in May next year.


The US patent on Lantus expires in February, but generic competition there may be delayed after Sanofi in January said it was suing Indianapolis-based Lilly over its plans to introduce a generic in the US Sales of the drug in Europe were less than 15 per cent of the total in 2013, because the price of the drug is far lower than in the US, which accounted for almost two-thirds of total Lantus sales, said Mark Clark, an analyst at Deutsche Bank 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 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 its once-a-day insulin injection 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 US approval to sell the drug in the first quarter of next year.