Alvotech and its marketing partner Teva are coming for Johnson & Johnson’s $9 billion Stelara crown. On Tuesday, Alvotech revealed positive results from a clinical study for AVT04, its proposed Stelara biosimilar.
In a randomized study, investigators found "therapeutic equivalence" between the drugs and saw no clinically meaningful differences in safety. The Icelandic biosimilar company tested the candidate against J&J's blockbuster immunology drug in patients with moderate to severe chronic plaque-type psoriasis.
Alvotech has partnered with Teva for potential U.S. marketing of its biosim. Earlier this month, Alvotech touted positive results from a pharmacokinetic similarity study.
J&J doesn’t have long before its U.S. composition of matter patent for Stelara expires in 2023, according to the company’s annual report. Stelara generated around 10% of J&J's global sales last year and is the healthcare conglomerate's largest product.
But Alvotech isn't alone in seeking to market a Stelara biosim. Amgen scored a win for its own product last month.
For its part, Alvotech has been busy battling AbbVie in court over its Humira biosimilar prospect. The companies had been disputing patents and alleged trade secrets theft, but recently settled their cases.
Now, Alvotech is set to launch its Humira copycat in the U.S. under a licensing deal with AbbVie that begins next July.
Stelara was the first biologic treatment to selectively inhibit the IL-12 and IL-23 pathways when it launched back in 2009. Alvotech has not yet submitted its Stelara biosimilar to the FDA.