AbbVie and Alvotech have settled their legal fight over Alvotech’s proposed generic version of AbbVie’s blockbuster arthritis drug called Humira. AbbVie will grant Alvotech a license to its Humira patents and let Alvotech create a U.S. biosimilar of the drug starting in July 2023, pending U.S. Food and Drug Administration approval, the Tuesday statement said.
Under the deal, Alvotech could launch its Humira copycat–approval pending–as early as next summer. AbbVie will grant Alvotech a license to its Humira-related patents in the U.S., which will take effect on July 1, 2023. Alvotech is on deck to pay royalties to AbbVie and it “acknowledges the validity and enforceability of the licensed patents,” AbbVie said in a release.
The resolution comes after the companies battled in court on two fronts. In a trade secrets lawsuit, AbbVie accused the Icelandic company of recruiting one of its manufacturing executives, who AbbVie says emailed himself sensitive information about Humira’s production just before leaving. In October, a federal judge in Illinois dismissed the case for lack of jurisdiction. AbbVie adopted a new tack in December, pushing the U.S. International Trade Commission (ITC) to bar imports or sales of Alvotech’s biosim in the U.S.
Alvotech says it’s the only known company to both develop a high-concentration Humira biosimilar and conduct a switching study, which could support potential approval as an interchangeable product. An interchangeability tag would allow pharmacists to substitute Alvotech’s product for brand-name Humira at the pharmacy counter.
AbbVie sells both low- and high-concentration Humira in the U.S., but more than 80% of the prescriptions are for the high-concentration strength, Alvotech says. Humira sales topped $20.7 billion in 2021, accounting for 37% of its total revenues and making it the best-selling pharmaceutical product in the world, excluding COVID-19 vaccines.
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