Ustekinumab biosimilar candidate achieves ‘therapeutic equivalence’
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AVT04, a biosimilar candidate to ustekinumab developed by Alvotech, met the primary endpoint in a confirmatory clinical study of patients with chronic plaque-type psoriasis, according to a company press.
The confirmatory trial — a randomized, double-blind, multicenter study — enrolled 581 patients throughout four centers in Europe and aimed to investigate the efficacy and safety profile of AVT04 compared with ustekinumab (Stelara, Janssen). The trial investigated the drug in patients with “moderate to severe chronic plaque-type psoriasis.”
“The progress of our proposed biosimilar to Stelara highlights the advantage of our global, vertically integrated platform,” Robert Wessman, founder and chairman of Alvotech, said in the press release. “Completing this clinical milestone, less than 1 year since we recruited the first subject, truly demonstrates the success of our clinical development and integrated approach to rapidly advancing multiple high-quality biosimilar candidates.”
AVT04 demonstrated “therapeutic equivalence” compared with ustekinumab and showed no meaningfully different safety results through 28 weeks of follow-up, the release said. The drug met the primary endpoint of Psoriasis Area and Severity Index percent improvement at 12 weeks. Secondary endpoints included quality-of-life scores, tolerability data, pharmacokinetic data, immunogenicity and safety data.
“We believe that using the same type of host cell line as the reference product enables matching the post-translational modifications to the best extent possible,” Mark Levick, CEO of Alvotech, said in the release.
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Alvotech press release
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