Alvotech and STADA obtain approval in Europe for ustekinumab biosimilar, UZPRUVO

On January 10, Alvotech announced that the European Commission (EC) issued a marketing authorization to its European commercialization partner, STADA, for UZPRUVO (AVT04), a biosimilar referencing STELARA (ustekinumab). The authorization covers all European Economic Area countries, as well as Iceland, Liechtenstein, and Norway. UZPRUVO is the first ustekinumab biosimilar to STELARA approved in Europe, and is eligible for market entry starting in July 2024, after STELARA’s European Supplementary Protection Certificate expires. The EC has indicated UZPRUVO for treatment of plaque psoriasis, pediatric plaque psoriasis, psoriatic arthritis, and Crohn’s disease. As previously reported by Big Molecule Watch, Alvotech creates AVT04 using an Sp2/0 host cell line and a continuous perfusion process.

Alvotech’s AVT04 has previously received marketing authorizations in Canada, through a partnership with JAMP Pharma Group; and Japan, through a partnership with Fuji Pharma. Stay tuned to Big Molecule Watch for future news about ATV04.