Where are all the generic insulins hiding?
Another biosimilar basal insulin product is one step closer to being available for public use in the United States.
Last July, U.S. pharmaceutical company Merck received tentative FDA approval for its Lusduna Nexvue product, a biosimilar insulin glargine delivered in a pre-filled pen. This February, Merck announced tentative FDA approval for a 10 ml vial of the insulin as well, expanding the company’s potential product line of basal insulins.
While both products, the vial and the pen, have satisfied all regulatory requirements for approval, neither can be launched in the U.S. until an outstanding patent infringement lawsuit between Merck and Sanofi, manufacturer of the Lantus basal pen and vial, is settled.
Lusduna Nexvue is essentially modeled after Lantus. It is also similar to the already-launched Basaglar, manufactured by Eli Lilly, which was also modeled after Lantus. According to a Merck press release, there are three ways to settle the outstanding litigation.
First, Sanofi and Merck could reach an agreement. Sanofi reached a similar agreement with Eli Lilly in 2015, ending a patent lawsuit over the launch of Basaglar. Lilly reportedly paid undisclosed royalties to Sanofi in exchange for the license to the disputed Lantus insulin patents.
A second path to settlement could come in the form of a court decision in the favor of Merck. Lastly, thirty months could elapse from the initial filing date (September 2016), after which time the lawsuit would effectively expire. Such a scenario would push the launch of Merck’s pen to 2019 and its vial to 2020.
Merck said that in all likelihood the vial won’t be fully approved by the FDA for another year.
Lusduna Nexvue is Merck’s first insulin product and marks a company that is more consciously expanding its diabetes platform into type 1 diabetes treatment needs. With its large market of primary care relationships, Merck believes it can make an impressive entry into the biosimilar basal insulin world, piggybacking on the success of Basaglar, which totaled $434 million in sales in 2017.
In general, “biosimilar” medicines are medicines that are priced lower than the original product from which they are based. Basaglar, for instance, came on to the market about 15 percent cheaper than Lantus.
According to Merck, drug price history suggests that at least two generics are needed on the market to lower costs in a meaningful way. The hope is that Lusduna Nexvue will continue the trend, carrying a further 15 to 20 percent reduction in basal insulin costs.
Basal insulin is designed to be injected once or twice daily. Long-acting, it provides a constant level of insulin action throughout the day. Basal insulin essentially helps one keep blood sugars at consistent levels when not eating. Prandial, or meal-time, insulins, on the other hand, are taken when eating to counteract blood sugar level spikes. They act rapidly on the body to bring down blood glucose levels.
In a study with more than 500 people with type 1 diabetes, Lusduna Nexvue displayed similar results to Lantus along the lines of ability to lower A1c, dose requirements and overall safety and patient tolerability. A separate study with more than 500 people with type 2 diabetes showed similar overlap between Lantus and Lusduna Nexvue.