US-based pharma giant AbbVie and Iceland-based Alvotech have agreed to settle a case filed with the International Trade Commission, which could open legal doors for biosimilars of Abbvie’s most profitable drug, according to BioSpace.
What was the dispute? AbbVie stated that Alvotech’s adalimumab biosimilar drug had been developed through the theft of trade secrets of its Humira product. The companies have not revealed how much money the settlement involved, but it did open legal doors for other companies to manufacture more Humira biosimilars.
Approved in December 2002, Humira (adalimumab) is a recombinant human IgGl monoclonal antibody specific for human tumor necrosis factor (TNF). It is indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, psoriasis, juvenile idiopathic arthritis, ulcerative colitis, Crohn’s disease, and certain types of uveitis.
The drug has become the highest-grossing pharmaceutical product in the world. AbbVie’s Humira sales increased to more than $20 billion in 2021. However, those profits are expected to face cuts after a potentially-approved competitor biosimilar drug launched in the United States in 2023.
Alvotech started working on a Humira biosimilar called AVT02, which worked exceptionally well in patients who had previously been treated with Humira. In addition, AVT02 produced the same levels of clinical efficacy, safety, and immunogenicity.
Despite the positive data, Alvotech faced legal trouble bringing its product to market, according to BioSpace. AbbVie has long maintained a monopoly on Humira, and Alvotech filed a federal lawsuit to end the monopoly.
In November 2020, the Food and Drug Administration (FDA) accepted Biologics Licensing Application (BLA) submitted by Alvotech. However, the FDA deferred action due to AbbVie’s lawsuits.
In September 2021, Alvotech’s product received a positive review from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
In February 2022, the FDA again accepted Alvotech’s BLA for review for AVT02, adding that it will reach a decision by December 2022.
Finally, the lawsuit from AbbVie has been removed. The settlement allows Alvotech a non-exclusive license to adalimumab biosimilar drug patents in the United States beginning in July 2023. Alvotech will pay royalties to AbbVie for licensing its Humira patents.
AVT02 could become the second-ever biosimilar to enter the U.S. market, after Amgen’s Amjevita, another adalimumab biosimilar, and Samsung Bioepis’ Hadlima. These biosimilars will hit the market in 2023, which will be more affordable.
Robert Wessman, Alvotech founder and chairman, said, “Our new product will be a game-changer that will provide consumers who are suffering from chronic pain with significant savings. We look forward to bringing this drug onto the market as soon as possible.”
