Alvotech announced that it has settled with Johnson & Johnson in the European Economic Area (EEA), Japan and Canada for its ustekinumab biosimilar, AVT04, and has provided guidance on its proposed launch dates in these regions. AVT04 received regulatory approval in January 2024 in Europe, in September 2023 in Japan and in November 2023 in Canada. The products will be marketed by Stada (as Uzpruvo®) in Europe from late July 2024, by Fuji Pharma in Japan (as Ustekinumab BS (F)) from May 2024, and by JAMP in Canada (as Jamteki®) from Q1 2024.
Alvotech’s applications for AVT04 elsewhere around the world are pending, including in the US.
In June 2023, Alvotech and Teva announced a US settlement with J&J relating to ustekinumab, with a market entry date of no later than 21 February 2025.