Lilly and Boehringer Ingelheim have won ‘tentative’ approval from the FDA for their version of Sanofi’s huge selling insulin glargine Lantus.
According to a statement released by the companies, the US regulator is satisfied that the insulin – known as Basaglar – is suitable for use in the treatment of people with diabetes, but cannot grant final approval as Sanofi has filed a lawsuit against Boehringer and Lilly claiming patent infringement.
Sanofi filed the lawsuit in January this year triggering an automatic 30-month stay of approval by the FDA, meaning Lilly and Boehringer cannot launch their insulin in the US until the middle of 2016 even thought the patent for Lantus is set to expire in 2015.
Both Basaglar and Lantus are based on insulin glargine and share the same amino acid sequence, meaning that Lilly and Boehringer’s medicine is generally viewed as a biosimilar of Lantus, which had sales of more than $7bn during 2013.
In Europe the Committee for Medicinal Products for Human Use (CHMP) recommended Lilly and Boehringer’s insulin glargine under the name Abasria as a biosimilar treatment for people with diabetes.
However, due to a technicality, the FDA does not view Basaglar as a biosimilar but as a unique biological treatment, further complicating the matter.
In addition to the lawsuit Sanofi is protecting its position as leaders in the insulin market with the development of Toujeo, touted as a direct successor to Lantus.
The FDA accepted the drug, which is a concentrated version of Lantus, for review earlier this year. Sanofi has high hopes for Toujeo due to its improved side effect profile over Lantus and other insulin glargines set to hit the market.
Competition is also set to come from Novo Nordisk, however, which is collecting data to resubmit its next generation insulin Tresiba for approval in the FDA after the first approval attempt was knocked back.
Despite the prospect of these advanced insulins, Lilly and Boehringer are confident that Basaglar has a place in the diabetes market.
Enrique Conterno, president, Lilly Diabetes, said: “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. 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.”