Eli Lilly and Boehringer Ingelheim have won tentative FDA approval for their insulin product Basaglar, which is considered the biosimilar of a Sanofi product in Europe but is being reviewed as its own NDA in the United States.
Tentative approval means Basaglar (insulin glargine injection) will be ready to market if and when Lilly and BI win a patent infringement lawsuit filed by Sanofi, owner of reference product Lantus, said Mike Mason, vice president of Lilly Diabetes.
Sanofi filed suit in January over Lilly and BI’s Basaglar NDA, which used Lantus safety and efficacy data as a supplement to clinical trials and pharmacokinetic and pharmacodynamics studies. That action put a hold on any Basaglar approval until mid-2016 or a court decision under Hatch-Waxman, Mason said.
While insulin technically is a biologic, it is one of several product classes that have historically been regulated by the FDA under its small molecule approval process as NDAs rather than BLAs, according to Christopher Mikson, an attorney with Jones Day.
Basaglar itself was submitted under the FDA's 505(b)(2) regulatory pathway, a hybrid between an original NDA and a generic ANDA, Mikson said.
The product is not exactly the same as Lantus, but it’s also not completely new, with the same amino acid sequence as the reference drug. As such, the companies could use the reference product to prove safety but were still required to conduct clinical studies and other testing not typically required of ANDA filers, he said.
Lilly and BI hailed the tentative approval as a major milestone for their basal insulin, which is meant to help diabetics achieve long-lasting control over their blood sugar.
In Europe, Basaglar recently earned a positive recommendation as a biosimilar application from the European Medicines Agency’s Committee for Medicinal Products for Human Use, Lilly and BI said. — Bryan Koenig
Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.