Lantus Follow-On Biologic Faces Additional Legal Barriers

This week, Sanofi announced that it has filed a lawsuit against Merck Sharp & Doheme Corp alleging patent infringement. The suit was filed in the United States District Court for the District of New Jersey, according to a press release.

Sanofi alleges that Merck is infringing on 2 patents for a follow-on biologic to insulin glargine (Lantus). The lawsuit was the result of the new drug application (NDA) for the product.

Sanofi reported that in the NDA, Merck included a paragraph IV certification challenging the patents and listed in the FDA Orange book for Lantus and Lantus SoloStar products, according to the release.

Insulin glargine was first approved in April 2000 to improve blood glucose control in patients with type 1 diabetes and type 2 diabetes.

In June, Merck announced positive results from a pair of phase 3 studies involving the drug MK-1293, the follow-on biologic insulin glargine (Lantus) for the treatment of patients with diabetes.

MK-1293 has the same amino acid sequence as insulin glargine, but cannot be considered a biosimilar because it is not identical, according to Merck.

During the comparison studies, the researchers did not find any clinically meaningful differences between groups taking the originator and the follow-on biologic regarding safety endpoints and found the follow-on biologic met non-inferiority endpoints, according to Merck.

Merck recently announced that the FDA granted tentative approval to Lusduna Nexvue (insulin glargine injection). While Lusduna Nexvue met regulatory requirements for follow-on biologics, due to the tentative approval, it is subjected to an automatic stay as a result of a patent infringement lawsuit brought by Sanofi in September 2016.

Despite approval, it is likely that Merck’s follow-on biologic will not enter the market soon due to the patent infringement lawsuits brought in 2016 and in August 2017.