On July 6, 2021 Alvotech announced the start of a comparative, confirmatory efficacy and safety clinical study comparing AVT04, Alvotech’s proposed ustekinumab biosimilar, to the reference product STELARA, in patients with moderate-to-severe chronic plaque psoriasis. The announcement states that the study is being conducted in five countries in Central and Eastern Europe and is expected to enroll about 530 patients.
The announcement further notes that, in parallel, Alvotech is also conducting a pharmacokinetic (PK) similarity study in Australia and New Zealand to demonstrate equivalent PK endpoints between AVT04 and STELARA, and that this study is also assessing safety and tolerability.
