Posted by Michael Wonder on 20 Jul 2017
Merck announces U.S. FDA grants tentative approval for Lusduna Nexvue (insulin glargine injection), a follow-on biologic basal insulin
20 July 2017 - Merck today announced that the U.S. FDA has granted tentative approval for Lusduna Nexvue™ (insulin glargine injection) 100 units/mL, a follow-on biologic basal insulin in a pre-filled dosing device.
Lusduna Nexvue is being developed by Merck with funding from Samsung Bioepis.
With the tentative approval, Lusduna Nexvue has met all required regulatory standards for follow-on biologics of clinical and non-clinical safety, efficacy and quality, but is subject to an automatic stay due to a lawsuit from Sanofi claiming patent infringement.
Under the Hatch-Waxman Act, the initiation of Sanofi’s lawsuit in September 2016 automatically invoked a stay on final FDA approval of Lusduna Nexvue for a period of up to 30 months, or in the event a court finds in favour of Merck, whichever comes sooner.
