|Lilly Diabetes President Enrique Conterno|
Eli Lilly ($LLY) and Boehringer Ingelheim won European clearance for their biosimilar of Lantus, Sanofi's ($SNY) top-selling insulin product, but the treatment's full potential remains hamstrung by a U.S. patent challenge.
The European Commission granted marketing approval for Abasria, the duo's take on the long-lasting insulin glargine that accounted for about $7.8 billion in global sales for Sanofi last year. The treatment has proven itself safe, effective and similar to Sanofi's product across 6 clinical trials, Lilly and Boehringer said, becoming the first insulin ever approved through the EU's biosimilar pathway.
But Lilly and Boehringer won't be able to mount a serious challenge to Sanofi's dominance until they can get their product on U.S. shelves, and a legal spat is keeping those plans on hold.
While Lantus is set to lose patent protection in February, Sanofi cannily filed a lawsuit earlier this year, triggering a 30-month delay for its encroaching rivals. Last month, the FDA handed down a tentative approval for Lilly and Boehringer's treatment, to be marketed as Basaglar in the U.S., but until the duo either settles up in court or waits out the clock, Lantus will remain the only insulin glargine on the stateside market.
As it stands, Lilly and Boehringer are on track for a 2016 U.S. launch of their biosimilar, by which point the market for insulin analogs may look much different. Merck ($MRK), with the help of a joint venture between Samsung and Biogen Idec ($BIIB), is working up a Lantus biosimilar of its own. And Sanofi has already filed applications in the U.S. and EU for Toujeo, a long-acting Lantus successor that could hit the American market before Lilly and Boehringer can roll out their biosimilar. Novo Nordisk ($NVO), previously dealt a blow with an FDA rejection of the next-generation insulin Tresiba, is now expecting to get that product on the U.S. market by 2016.
But the EU nod is a step in the right direction for Lilly and Boehringer's 3-year-old diabetes alliance, giving the pair a chance to compete in a market that brought in $1.1 billion in Lantus sales for Sanofi last year.
"We believe that insulin glargine will continue to be widely used for many years, and Lilly and Boehringer Ingelheim are committed to addressing the needs of people living with diabetes and providing support beyond the medicine," Lilly Diabetes President Enrique Conterno said in a statement.
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