With biosimilars to AstraZeneca’s blockbuster rare blood disease med Soliris recently available in the U.S., nonprofit health plan EmblemHealth is taking a shot at the company and its alleged patent misuse in court.
Soliris (eculizumab) was first approved for paroxysmal nocturnal hemoglobinuria (PNH) in 2007 under Alexion, which later became AstraZeneca’s rare disease unit after its $39 billion buyout in 2020. The drug has since collected additional nods in atypical hemolytic uremic syndrome (aHUS), generalized myasthenia gravis (gMG) and pediatric gMG, plus neuromyelitis optica spectrum disorder. The drug now competes with other PNH drugs from Novartis and Apellis, but for years it was the only option for patients suffering from the rare blood disease, reaching blockbuster status in 2016.
Soliris entered the market with a 14-year patent that was set to expire in 2021, according to EmblemHealth's 171-page complaint filed Wednesday in the U.S. District Court for Massachusetts, which names Alexion as a defendant. Alexion later added five “fraudulent” extra patents through "deceptive" means and asserted them against would-be biosimilar competitors to delay biosimilar entry until 2025, the complaint alleges.
At more than $650,000 per year before discounts, Soliris was, for a time, one of the most expensive drugs in the U.S. Overpayments purchasers made through the four-year delay of cheaper biosimilars are “estimated to exceed $2 billion,” EmblemHealth claims.
The New York-based health plan looks to lead the charge for a class of Soliris buyers and seeks unspecified monetary relief in damages that should be doubled or trebled “where appropriate.”
“Alexion’s wrongful actions in improperly maintaining its monopoly over the eculizumab market in the United States has allowed it to make billions in additional profit at the expense of purchasers,” EmblemHealth alleges in the complaint.
AstraZeneca cannot comment on the litigation, a spokesperson said.
Meanwhile, Soliris' U.S. exclusivity recently ended, with Amgen’s interchangeable Bkemv hitting the market last month thanks to a 2020 settlement between Alexion and Amgen. In addition, Teva and Samsung Bioepis launched their version, Epysqli, last week at a 30% discount to Soliris.
Soliris generated $2.5 billion in 2024 sales, an 18% decline from the prior year. To offset the declines expected from biosimilar competition, AstraZeneca has for years been working to transition patients to its Soliris follow-on Ultomiris.