Alvotech announces expected global market entry dates for AVT 04 biosimilar to Stelara (ustekinumab)

Alvotech announced that it has reached settlement agreements with Johnson & Johnson in Japan, Canada and in the European Economic Area (EEA) for AVT 04, a biosimilar to Stelara (ustekinumab).

Regulatory approval for AVT 04 in these markets has already been granted. Market applications for AVT 04 are currently pending in additional global markets, including in the U.S.

Market entry of AVT 04 in Canada is expected in Q1 2024. Launch of AVT 04 in Japan is anticipated after the upcoming round of National Health Insurance reimbursement price listings, in May 2024. Entry to the first European markets is expected as soon as possible after the expiration date of the European Supplementary Protection Certificate (SPC) for Stelara, which is in late July 2024.

Market authorization for AVT 04 in Japan is held by Alvotech’s commercial partner Fuji Pharma Co. Ltd., where the biosimilar will be marketed as Ustekinumab BS (F). Alvotech’s commercial partner and market authorization holder for AVT04 in Canada is JAMP Pharma Group, where the biosimilar will be marketed as Jamteki. In the EEA, Alvotech’s commercial partner and market authorization holder for AVT04 is STADA Arzneimittel AG, where the trade name for AVT04 will be Uzpruvo.

In June 2023, Alvotech and Teva, the commercialization partner for AVT 04 in the U.S., reached a settlement and license agreement with Johnson & Johnson, that grants an entry date for AVT 04 in the U.S. no later than February 21, 2025, pending approval of the Biologics License Application by the FDA which is expected by the Biosimilar User Fee Act goal date of April 16, 2024.