Alvotech Announces More Settlements and Expected Launch Dates Regarding Biosimilar to STELARA (ustekinumab), AVT04

On February 15, Alvotech announced that it reached more settlement agreements with Johnson & Johnson for ATV04, Alvotech’s biosimilar to STELARA (ustekinumab).  The settlements cover Canada, the European Economic Area, and Japan, clearing the way for Alvotech to launch AVT04 in those markets, where AVT04 has already received regulatory approval.  Alvotech also announced that it expects to launch AVT04 in Q1 2024 in Canada, May 2024 in Japan, and late July 2024 in the European Economic Area.

Alvotech has commercial partners for AVT04 in each of the aforementioned markets.  In Canada, their partner is JAMP Pharma Group, and the biosimilar will be marketed as JAMTEKI.  In the European Economic Area, their partner is STADA, and it will be marketed under the name UZPRUVO.  Lastly, in Japan, Alvotech has partnered with Fuji Pharma, and AVT04 will hit the market as USTEKINUMAB BS (F).

Alvotech is still awaiting FDA approval of AVT04 in the United States, but has already secured a licensing agreement with Johnson & Johnson for the U.S. market.  Per the settlement agreement, AVT04 can be marketed in the U.S., subject to regulatory approval, no later than February 21, 2025.

Stay tuned to Big Molecule Watch for more Alvotech and AVT04 updates.