- The FDA on Wednesday approved Eli Lilly's diabetes drug Basaglar (insulin glargine) as a 'follow-on' biologic. Notably, it declined to label Basaglar a biosimilar, as the E.U. did last year.
- Basaglar is the first insulin product to be approved through the shortened 505(b)(2) approval process. As part of its 505(b)(2) application, Lilly demonstrated the drug was sufficiently similar to Sanofi's existing diabetes med Lantus.
- The drug is approved for treatment of type 1 diabetes in adult and pediatric patients, and in adults with type 2 diabetes.
Lilly had received tentative approval of Basaglar in August of 2014, but the FDA declined to grant final approval due to ongoing patent litigation between Sanofi and Lilly. In September, the two companies reached a settlement allowing Lilly to market a copy of Sanofi's Lantus, beginning in December 2016.
In this decision, the FDA did not approve Basaglar as a 'biosimilar,' instead deeming the drug a 'follow-on' biologic. In order for the FDA to consider a drug a biosimilar, the drug needs to be highly similar to an existing approved reference product as well as demonstrating no clinically meaningful differences. In this case, there are no existing approved reference products under the Public Health Service Act, which governs the process. Lantus was approved under another law.
Lilly did demonstrate that Basaglar was sufficiently similar to Lantus, however. The company additionally submitted Basaglar-specific clinical data, based on two trials with 534 and 744 patients respectively.
A Lilly spokesperson told Reuters Basaglar will be priced lower than Lantus, but no final price has been set yet. Lantus earned more than $8 billion in 2014 sales.