Merck & Co., Inc. (“Merck”) announced last week that the FDA has granted tentative approval for its insulin glargine injection LusdunaTM NexvueTM, a follow-on biologic to Sanofi’s Lantus®. Because Merck’s application for insulin glargine was filed using the abbreviated 505(b)(2) regulatory pathway provided by the Hatch-Waxman Amendments (not a section (k) application under the BPCIA), the product is properly characterized as a follow-on biologic, not a biosimilar.
Insulin glargine is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. According to Merck, LusdunaTM NexvueTM is being developed with funding from Samsung Bioepis.
Sanofi and Merck are currently involved in patent litigation related to this application. Sanofi filed a suit against Merck in the United States District Court for the District of Delaware in September 2016. See Sanofi v. Merck, Civ. No. (D.Del.). As a result of the litigation, final approval of Merck’s application is subject to the automatic 30-month stay of approval provided by Hatch-Waxman. This is not the first follow-on biologic for insulin glargine. In December 2015, the FDA granted final approval to Basaglar®, Eli Lilly’s follow-on insulin glargine product.
Several other companies are reportedly developing insulin glargine products. In June of this year, Mylan filed IPR petitions on two of Sanofi’s patents related to insulin glargine, as reflected in RFEM’s IPR Dashboard.