FDA Grants Tentative Approval to Follow-On Insulin Lispro, Admelog

The FDA has granted tentative approval of Sanofi’s follow-on insulin lispro injection, Admelog. Referenced on the originator product, Humalog, Sanofi’s insulin lispro is a rapid-acting human insulin analog indicated to improve glycemic control in adults and children with diabetes.

"Sanofi is committed to broadening our portfolio of products to help people living with diabetes manage their blood sugar," said Stefan Oelrich, senior vice president and head of the global diabetes franchise for Sanofi. "With this tentative approval, we are now one step closer to offering Admelog as an option for those who use rapid-acting insulin."

As was the case with Merck’s recent tentative approval for its insulin glargine follow-on product, Lusduna, the FDA will not grant final authorization for Admelog until patent litigation has concluded.

The drug’s tentative approval is based on its similarity to its reference product, though in the United States, follow-on insulin products are not regulated as biosimilars. Because the FDA treats innovator insulins as drugs, rather than as biologic products, treatments such as Admelog are regulated as follow-ons. Thus, Sanofi will have to address any patent infringement claims under the Hatch-Waxman Act, which governs the generic drug approval process, rather than under the Biologics Price Competition and Innovation Act.

In May, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on Admelog—which is regulated as a biosimilar in Europe—and recommended that the product be granted a marketing authorization. The CHMP’s positive opinion was based on Sanofi’s clinical development program that enrolled over 1000 adults with type 1 or type 2 diabetes. The program included a pharmacokinetic and pharmacodynamic phase 1 study, as well as 2 multicenter phase 3 clinical trials that evaluated the safety and efficacy of the follow-on compared with the reference insulin lispro. In addition, a safety study was conducted with the lispro biosimilar used in insulin pumps in adults with type 1 diabetes.