Lilly grabs a 'tentative' FDA OK for insulin treatment, but Sanofi still blocks its path

Enrique Conterno, president, Lilly Diabetes

Eli Lilly has won a "tentative" FDA approval for its knockoff of Sanofi's Lantus, but don't look for it at a pharmacy anytime soon. The insulin glargine injection--to be marketed as Basaglar eventually in the U.S.--faces an automatic 30-month stay after Sanofi filed a suit against Lilly and its partner Boehringer Ingelheim claiming patent infringement.

According to Lilly ($LLY), the FDA determined that Basaglar had what it takes to win marketing approval, but Sanofi ($SNY) holds the keys to the market until the middle of 2016, unless Lilly's legal team can wrest them away sooner.

The approval comes shortly after the delayed SGLT2 diabetes drug empagliflozin won a green light from regulators. Lilly badly needs to make progress on the development front as cheap generics eat into its top franchises. But Sanofi won't be stepping aside to help, relying on billions in annual Lantus cash, which will start to shrivel once it loses patent protection next year.

In the meantime, Lilly is hard at work on its application for dulaglutide, a GLP-1 drug that analysts see as its main near-term hope for building a new blockbuster franchise. Aside from one or two cancer drugs, Lilly has grown increasingly focused on its prospects in diabetes, a booming field that requires massive late-stage studies and plenty of time for regulatory reviews. 

Basaglar recently received a positive recommendation from the Committee for Medicinal Products for Human Use, a division of the European Medicines Agency, which considers the insulin treatment a biosimilar. For technical regulatory reasons, Basaglar is not considered a biosimilar in the U.S.--even though it is one.

Sanofi, meanwhile, has been using the extra time it's buying in the courts to advance U300, a new and improved version of Lantus. And Novo Nordisk ($NVO) is advancing its marketing of Tresiba, meanwhile, as it hustles along new clinical work to win the FDA's approval.

"The tentative approval for Basaglar is another step toward providing an important option for people with diabetes in the U.S. who need basal insulin treatment," said Enrique Conterno, president, Lilly Diabetes.  "We believe insulin glargine will continue to be used widely 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."

- here's the release

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