Alvotech and AbbVie announce US adalimumab settlement

Alvotech announced that it has settled all pending US disputes with AbbVie, including the ITC case brought by AbbVie in December 2021.  Under the settlement Alvotech will receive non-exclusive rights to market AVT02 (high-concentration, citrate-free biosimilar adalimumab) in the United States from 1 July 2023.  This date is the same US license date AbbVie granted to Coherus and Boehringer Ingelheim in their respective settlements with AbbVie, which follows Amgen’s US license date of 31 Jan 23 and Samsung’s 30 June 2023.  Alvotech is the only known company that has both developed a high-concentration biosimilar adalimumab and conducted switching studies to enable the launch of what is expected to be the first high concentration interchangeable biosimilar adalimumab in the US.  Teva is Alvotech’s strategic partner for the US commercialisation of AVT02.  AVT02 is already approved in Europe, Canada and the UK.