In a big win for AbbVie and its best-selling drug—which also happens to be the biggest med in the world—the company scored another Humira biosimilars settlement that makes it "increasingly unlikely" copycats will launch in the U.S. before 2023. But in Europe, the threat will arrive much sooner.
After inking a similar deal with Amgen last year, AbbVie on Thursday announced a global patent settlement with Samsung Bioepis that pushes out by several years a Humira biosim launch in the U.S.
Under the deal, Samsung's commercialization partner for Europe, Biogen, can launch the Humira biosim there on a "country-by-country basis" starting this October. Merck & Co., Samsung's commercialization partner for the U.S., can launch in June 2023. The biosim, Imraldi, already has European approval, but hasn't yet made it past U.S. gatekeepers.
AbbVie's agreement allows Amgen to launch its copy in the U.S. months earlier, in January 2023. Its EU debut is scheduled for this October. Both deals include royalty payments to AbbVie, according to the companies.
The Humira market in Europe is worth about $4 billion, Amgen's biosimilars general manager Scott Foraker said in a statement at the time of his company's deal.
On Thursday, Jefferies analyst Ian Hilliker wrote that the "fact that a second biosimilar developer has given up on litigating around the Humira [intellectual property] in favour of a settlement helps to further underpin the strength of AbbVie's IP around Humira."
He added that it now seems "increasingly unlikely" that other biosim developers will be able to negotiate for U.S. launch dates earlier than 2023. Jefferies is predicting global Humira sales will peak at $20.9 billion next year.
But while biosims start to grab up share in markets outside of the U.S., don't expect any quick downfall for the world's bestselling medication that generated 65% of AbbVie's sales last year. Humira generates most of its sales in the States, and Jefferies predicts U.S. sales for the drug won't peak until 2022—at the whopping figure of $18 billion. Price hikes will likely play a role, as the company has already taken routine increases in recent years that have more than doubled Humira's list price and helped fuel its astronomical sales growth.
At the time of the Amgen deal, Jefferies analyst Jeffrey Holford wrote that the settlement "increases visibility" for AbbVie as it transitions from "HumiraCo." to "NewCo." He said he still expects "noise" on the Humira biosim issue occasionally because so many companies are developing copycats.
Novartis, Fujifilm Kyowa Kirin Biologics, Coherus and Fresenius Kabi are also working on Humira biosims. Boehringer Ingelheim also has an FDA-approved Humira biosimilar and faces a patent lawsuit from AbbVie.
Editor's note: This story was corrected to reflect that Samsung Bioepis was a primary party in the settlement and that Merck & Co. is partnered with Samsung for the U.S. biosim launch.