Merck Receives Tentative FDA Approval for Lantus Follow-On

gloved hand withdraws drug solution with syringe

On July 20, 2017, Merck & Co. announced that the FDA granted tentative approval of its 505(b)(2) application for Lusduna™ Nexvue™ (insulin glargine injection), its follow-on version of Sanofi SA’s Lantus. Merck’s product reportedly met all of the required regulatory standards. According to Merck, however, final FDA approval is subject to an automatic stay pending the resolution of suit brought by Sanofi. Lusduna Nexvue was developed by Merck with funding from Samsung Bioepis. Like all transitional biologics, we expect the NDA for Lusduna Nexvue will be transitioned to a Biologics License Application (BLA) in 2020, although it is unclear whether the FDA will treat it as a full BLA or a biosimilar.