Sanofi’s 2016 lawsuit invokes a 30 month stay on final FDA approval.
The US Food and Drug Administration (FDA) has granted tentative approval to Merck’s insulin glargine injection (LUSDUNA Nexvue), pending the outcome of a 2016 lawsuit between the company and French drug maker Sanofi.
Merck’s insulin glargine injection 100 units/mL is a follow-on biologic basal insulin in a pre-filled dosing device, according to a Merck statement, that is being developed by Merck with funding from Samsung Bioepis. A follow-on biologic is a similar, but not identical, version of an approved reference product.
Sanofi’s lawsuit claims that the insulin glargine injection is a patent infringement of Lantus — the company’s best-selling diabetes treatment – and its SoloStar injection pen. The suit alleges that Merck purposefully developed insulin glargine injection using Sanofi’s patented products to damage their sales.
Under the Hatch-Waxman act, Sanofi’s September 2016 lawsuit automatically invokes a stay on final FDA approval for a period of up to 30 months, or if a court finds in favor of Merck, whichever comes sooner, according to a Merck statement.
The FDA’s tentative approval of the drug means that insulin glargine injection has met the agency’s regulatory standards for follow-on biologics of clinical and nonclinical safety, efficacy and quality.
“The tentative approval of LUSDUNA Nexvue is an important milestone, bringing us closer to offering this medicine to patients,” said Sam Engel, MD, associate vice president, Merck clinical research, diabetes, endocrinology and women’s health.