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FDA Tentatively Approves “Biosimilar” Basal Insulin, LUSDUNA Nexvue

By Isabel Chin

A new basal insulin is on the horizon in the US with Merck’s LUSDUNA Nexvue, but launch timing obscured by ongoing lawsuit

On July 20, the FDA granted tentative approval for Merck’s LUSDUNA Nexvue, a “biosimilar” basal insulin injection for people with both type 1 and type 2 diabetes. The delay in obtaining ­full approval comes from an ongoing patent infringement lawsuit filed by Sanofi that will have to be resolved before LUSDUNA Nexvue can become available. It is not clear when that will be. Being a “biosimilar” insulin glargine means that LUSDUNA Nexvue is modeled after the popular basal insulin Lantus (read more on “biosimilar” insulins here), similar to the already-launched Basaglar.

In general, “biosimilar” medicines are priced lower than the original product; Basaglar, for instance, is 15% cheaper than Lantus. Many hope that LUSDUNA Nexvue will follow a similar trend. Paying less doesn’t necessarily mean inferior quality, however, as LUSDUNA Nexvue performs similarly to Lantus. In a study with over 500 people with type 1 diabetes, LUSDUNA Nexvue was shown to have similar results to Lantus in ability to lower A1c, dose requirements, and overall safety and tolerability. A separate study with over 500 people with type 2 diabetes showed similar insulin dose requirements, safety, tolerability, and lower A1c levels between Lantus and LUSDUNA Nexvue.

However, the patent infringement lawsuit filed by Sanofi in September 2016 has automatically placed a hold on the final approval decision. LUSDUNA Nexvue will not be eligible for full approval by the FDA until Merck and Sanofi reach a settlement, a court decides in favor of Merck, or 30 months pass from when the lawsuit was filed (which will be March 2019). Lilly/BI’s “biosimilar” basal insulin, Basaglar, ran into a similar legal roadblock (read more about it here), but eventually gained full FDA approval.

Once fully approved, the “biosimilar” basal insulin will be indicated for both type 1 and type 2 diabetes. Historically, Merck has not had a presence in the insulin market, so LUSDUNA Nexvue signifies a new foray for the pharmaceutical company.