FDA Grants Tentative Approval to Merck’s Insulin Glargine Copycat

The FDA granted tentative approval for Merck’s Lusduna Nexvue (insulin glargine injection), as a follow-on basal insulin biologic, a product similar to Sanofi’s flagship Lantus treatment.

Lusduna Nexvue, with a pre-filled dosing device, was developed by Merck with funding from Samsung Bioepis. It is technically not considered a biosimilar product, based on its FDA approval pathway.

Final approval is delayed pending the outcome of a patent infringement lawsuit filed by Sanofi in September 2016. The suit triggered a 30-month hold on the product’s full approval, unless the court decides the patents are not infringed or the case is settled before that time. Otherwise, Lusduna Nexvue has met all required regulatory standards, Merck said.