AbbVie has inked a series of patent settlements with biosimilar makers allowing U.S. copycat launches to the world's bestselling medicine in 2023. With the first Humira biosim launches a little under 2 years away, Alvotech is hoping to find another route to the market.
Alvotech Tuesday morning said it had filed a federal lawsuit against AbbVie seeking to end the pharma juggernaut's "wrongful monopoly" on the world's best-selling drug.
Like other biosim makers, Alvotech has accused AbbVie of deploying the now-infamous Humira "patent thicket" to delay the introduction of its biosimilar AVT02. But unique to Alvotech, the company says its biosimilar is the first-filed copycat equal in strength to Humira's latest formulation, which AbbVie markets as a high-concentration, pain-free version of the drug.
In its suit, Alvotech claims that AbbVie sought to "overwhelm" the company with more than 60 patent claims of "questionable validity," the biosim maker said in a statement on the lawsuit.
The company laid out a string of allegations against AbbVie, including patenting "purported" inventions that aren't actually used to make Humira, seeking multiple patents on the same invention "but as part of different patent families," in a bid to sew confusion, and winning patents through "inequitable conduct."
The lawsuit comes shortly after AbbVie sued Alvotech in late March. In that suit, AbbVie accused Alvotech of recruiting a former manufacturing exec to purloin secrets on Humira production. Alvotech didn't play sitting duck, announcing the next day in a statement that it "strongly disputes" AbbVie's claims.
AbbVie claims that shortly before leaving the company—and after he was recruited by Alvotech—the former AbbVie exec “transmitted confidential and proprietary” information to a personal email account.
Despite a strong showing in 2020, Humira's days at the top are numbered, with the first round of U.S. biosimilar challengers set to enter the fray in early 2023. Meanwhile, the drug has already faced pressure from copycats in Europe and Japan.
Amgen has locked up a deal with AbbVie to roll out its biosimilar on January 31, 2023, while Pfizer has agreed to launch its copycat on November 20, 2023. Like Alvotech, Germany's Boehringer Ingelheim also fought hard to cut through Humira's patent thicket, but in 2019, the companies settled, with both agreeing to a launch of BI's biosim on July 1, 2023. BI—and now Alvotech—were among a few holdout companies seeking to hit the market before 2023.
With the patent cliff fast approaching, AbbVie is confident that immunology upstarts Skyrizi and Rinvoq can pick up the slack in coming years. Skyrizi, approved in plaque psoriasis, drummed up $1.6 billion in 2020, while rheumatoid arthritis med Rinvoq posted $730 million for the year.