Ring Around the Courtroom: The Wait for U.S. Biosimilar Insulins
Editor’s Note: in a breaking news update, Merck has announced that they have terminated worldwide commercialization of Lusduna – biosmilar insulin glargine. Lusduna was due to reach market following the settlement of a patent infringement lawsuit filed by Sanofi.
As we detailed earlier this summer, supply-side economics has an ugly hold on the insulin industry. Demand is high, and three companies (Lilly, Novo Nordisk, and Sanofi) hold 96% of the total insulin market by value, according to the American Diabetes Association.
At some point something has to give. So what about the biosimilar (read: generic) insulin market? Is there actual hope there for seeing decreased insulin costs or a wider array of available medicines? What needs to happen for that speculation to be realized? And why is everyone always suing everyone?
Biosimilars are approved copies of already marketed biological medicines. They essentially provide an alternative to existing biological medicines that have lost patent protection.
In general, biosimilar medicines are priced lower than the original product from which they are based. Drug price history suggests that at least two generics are needed on the market to lower costs in a meaningful way. If we look at biosimilar insulins, there does appear to be hope for decreased prices, but not as much as some may believe.
In the United States, “generic” versions of drugs typically carry a 50 to 80 percent price discount. Those are huge savings for people. Unlike most generics, though, biosimilar insulins (and other biosimilars in general) are much more expensive to manufacture.
Still, they do represent a discount.
Nearly 100 years into its medical life, insulin in the United States finally had its first generic in 2015. That December 2015, the Food and Drug Administration (FDA) approved the long-acting biosimilar insulin Basaglar (manufactured by Eli Lilly) for marketing. Similar to Sanofi’s biological, brand-name insulin Lantus, Basaglar’s approval was partly predicated on the safety and efficacy of Lantus. It came on the market in early 2017 (after a patent lawsuit between Sanofi and Eli Lilly was settled) about 15 percent cheaper than its precursor ($235 versus roughly $280 for Lantus).
Two other biosmilar insulins, Admelog (short-acting mealtime) and Lusduna (long-acting basal), have since been approved, but only Admelog has reached the market. For comparison, consider that biosimilar insulins have been available in India (Glaritus, Glarvia, Basalog, Wosulin, Insugen, Biosulin), China (Basalin, Comonlin, Prandilin), Mexico (Bonglixan), Europe (Abasaglar) and other parts of Asia for more than a decade.
Just like Nordisk and Lilly are loathe to let go of brand-name insulin shares, companies are battling to fight off the entry of generics as well. Litigation has severely slowed both the development and release of biosimilars in the United States and prevented diversification in the insulin market.
The above-mentioned Lusduna Nexvue, which was developed by Merck and received tentative FDA approval last summer, is the next biosimilar poised to hit the market. The hope is that it will carry a further 15 to 20 percent reduction in long-acting generic insulin costs, making an under-$200 insulin high end generic insulin available in the United States for the first time.
It’s release, however, is again tied up by Sanofi litigation. Like Basaglar, Lusduna Nexvue is also based on Sanofi’s Lantus. In January, Merck moved for summary judgment of non-patent infringement based on the grounds that the existing patent had expired along with the license to certain components of the injector pen that holds and delivers the insulin. In May, a Delaware court denied the request for summary judgment, leaving Merck’s time-line for market release in limbo.
So Sanofi sues Eli Lilly. Then Sanofi sues Merck. What gives?
In short, market share. With each successful generic insulin that hits the market based on its product, Sanofi faces potential profit losses. It all raises the question of when increased quality of life and decreased medical costs buck the proprietary nature of the drug industry and the hunger of profits.
Sadly, if current evidence is any indicator, it may be a while.
Even with the constant lawsuit game, there is a path for biosimilars reaching the market. It’s just a long one.
Merck has said that there are three ways to settle the outstanding patent litigation. First, the two parties in a suit can reach an agreement. That’s what happened in 2015 between Lilly and Sanofi, when Lilly reportedly paid undisclosed royalties to Sanofi in exchange for the license to the disputed patents. Second, a court can rule in the defendants favor, which, in the case of Merck, did not happen. Third, thirty months can elapse from the initial lawsuit filing date, after which the lawsuit effectively expires. Such a scenario would push the launch of Merck’s biosimilar to about 2020.
The wait goes on.
Read The Insulin Pricing Machine by Greg Brown.