Alvotech Schedules Global Market Entry for AVT04 Biosimilar
Biotech firm Alvotech has reached settlement agreements for its AVT04 biosimilar to Stelara® (ustekinumab) in Japan, Canada, and the European Economic Area. Regulatory approvals are already in place for these markets.
Biotech company Alvotech announced on February 15, 2024, that it has finalized settlement agreements with Johnson & Johnson regarding the market entry of AVT04 in Japan, Canada, and the European Economic Area (EEA). AVT04 is a biosimilar to Stelara® (ustekinumab), and regulatory approval has already been granted in these regions.
Market entry in Canada is expected in the first quarter of 2024. In Japan, the launch is anticipated in May 2024, following the upcoming national health insurance reimbursement price listings. Entry into European markets is planned shortly after the expiration of Stelara's European Supplementary Protection Certificate (SPC) in late July 2024.
For the U.S. market, a 2023 settlement agreement between Alvotech, its partner Teva, and Johnson & Johnson grants AVT04 market entry no later than February 21, 2025. The Biologics License Application (BLA) is expected to be approved by the U.S. Food and Drug Administration (FDA) by its user fee goal date of April 16, 2024.
Robert Wessman, Chairman and CEO of Alvotech, stated the company looks forward to working with its commercial partners to launch the biosimilar and increase patient access to the therapy. In Japan, AVT04 will be marketed as Ustekinumab BS (F) by Fuji Pharma; in Canada as Jamteki® by JAMP Pharma Group; and in the EEA as Uzpruvo® by STADA Arzneimittel AG.