AbbVie and Alvotech settle all US Humira litigation
AbbVie and Icelandic biosimilar company Alvotech have settled all US litigation over Alvotech’s proposed generic of AbbVie’s blockbuster arthritis treatment Humira (adalimumab).
The settlement grants Alvotech non-exclusive rights to the Humira patents and the right to market its biosimilar adalimumab candidate in the US starting July 1, 2023.
Róbert Wessman founder and chairman of Alvotech said in an press release announcing the settlement: “We aim to be the first interchangeable, high-concentration biosimilar to this critical treatment. We view today as a key milestone for patients and for our mission to fight for healthcare sustainability.”
AbbVie confirmed that the settlement will bring an end to all pending US litigation, including a recent Section 337 investigation at the US International Trade Commission (ITC) which began in December 2021.
While other companies are developing biosimailrs of the drug and have received regulatory approval, including Amgen, Boehringer, Ingelheim, and Pfizer, AbbVie has taken umbrage with Alvotech, Ivers-Lee and Teva’s biosimilars, which it claims were developed using stolen trade secrets.
Abbvie claimed that AlvoTech hired several employees knowledgeable of the Humira manufacturing process, one of which allegedly stole “confidential documents” when they left the company.
AbbVie has enjoyed an almost two-decade monopoly on the blockbuster drug, which remains the single highest-grossing drug in the US, excluding the COVID-19 vaccines. Last year, the drug netted AbbVie $20.7 billion in sales.
Alvotech’s AVT02 Humira biosimilar has received approval in Europe, Canada, and the UK. The biosimilar is still awaiting approval, with inspections scheduled in Q1 and Q2 of 2022.
