Merck gains tentative US approval for Lantus follow-on biologic

The US Food and Drug Administration (FDA) has granted tentative approval for Lusduna Nexvue (insulin glargine injection), a follow-on biologic basal insulin in a pre-filled dosing device.

Lusduna Nexvue is being developed by US pharma giant Merck & Co (NYSE: MRK) with funding from Samsung Bioepis, a joint venture between Samsung BioLogics and Biogen. The ‘copy’ product gained approval as a biosimilar in Europe in January this year.

With the tentative approval, Lusduna Nexvue has met all required regulatory standards for follow-on biologics of clinical and nonclinical safety, efficacy and quality, says Merck, but is subject to an automatic stay due to a lawsuit from French pharma major Sanofi (Euronext: SAN) claiming patent infringement of its blockbuster branded product Lantus (insulin glargine). 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 favor of Merck, whichever comes sooner. Lantus generated sales of around $6.6 billion in 2016.