Alvotech, the Icelandic holdout battling AbbVie in court over its Humira biosimilar, has reached an accord with the U.S. pharma giant. With a settlement in place, the companies are putting all patent and trade secret litigation to bed.
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 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 the company 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.
Separately, Alvotech sought to challenge AbbVie’s now-infamous Humira “patent thicket” in a patent lawsuit where a ruling was expected by the end of October.
Both cases have now been resolved.
“We aim to be the first interchangeable, high-concentration biosimilar to this critical treatment,” Robert Wessman, founder and chairman of Alvotech, said in a statement. “We view today as a key milestone for patients and for our mission to fight for healthcare sustainability.”
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, making it the best-selling pharmaceutical product in the world, excluding COVID-19 vaccines.
Alvotech’s Humira biosim has already snagged approval in Europe, Canada and the United Kingdom. In the U.S., where the company is handing off marketing duties to Teva Pharmaceutical Industries, Alvotech hit a regulatory snag in September. That month, the FDA said it was delaying a decision on Alvotech’s product until it can complete manufacturing site inspections. Since the start of the COVID-19 pandemic, numerous biopharma companies have been hit by travel restrictions that put off timely FDA site inspections.
The FDA is set to inspect the necessary Alvotech facilities in the first and second quarter of 2022, the company said.
In February, Alvotech said the FDA had received its biosimilar application for review, which included new data supporting interchangeability between the copycat and Humira proper. The FDA plans to deliver a verdict on Alvotech’s product by Dec. 2022, Alvotech said last month.
Still, Alvotech likely won’t be the first to tap the lucrative Humira market, and it’s not the only player in town with interchangeability ambitions. Back in October, Boehringer Ingelheim said its drug Cyltezo scored FDA approval as the first interchangeable Humira biosim. Under its settlement with AbbVie, BI can’t launch its low-concentration biosimilar until July 1 of next year.
Meanwhile, under a 2017 deal, Amgen could launch the first Humira biosimilar on Jan. 31, 2023. Several other biosim players have negotiated with AbbVie for staggered launches throughout next year.