The US Food and Drug Administration gave its approval on July 20 to Merck’s version of insulin glargine. Although not technically a biosimilar, it is suffering a fate like that of multiple biosimilars—approved but in launch limbo owing to patent litigation issues.
Merck applied for approval of its insulin product under the 505(b)(2) pathway (not the 351[k] biosimilar pathway), which essentially makes it another biologic brand, not a biosimilar. The first insulin glargine follow-on product, Basaglar® (Lilly), utilized the same abbreviated pathway to approval; however, Lilly agreed to a patent settlement with the originator manufacturer, Sanofi, allowing Lilly to launch Basaglar in December 2016. Merck performed separate clinical studies to prove its product’s noninferiority to Lantus®, as well as relying on Lantus data in its application.
Under Hatch-Waxman Act rules, Merck will have to either wait for the final positive ruling by the US District Court in Delaware on the patent litigation or 30 months after the initial filing of Sanofi’s lawsuit (in September 2016), whichever is earlier. This could potentially result in a launch in 2019, providing a compelling incentive for Merck to come to a licensing agreement with Sanofi.
In another connection with biosimilars, Merck developed the drug along with its biosimilar partner Samsung Bioepis.
Whenever the launch takes place, Merck will brand their insulin glargine drug Lusduna Nexvue, which will be available as a prefilled syringe.