Ahead of an imminent US Food and Drug Administration decision on its application, Alvotech has announced top-line results from a Phase III study in patients demonstrating biosimilarity of repeated switches between AbbVie’s Humira (adalimumab) and the Icelandic firm’s high-concentration 100mg/ml biosimilar candidate, AVT02, compared to administration of the reference brand without switching.
The AVT02-GL-302 study – which began at the end of June last year – evaluated pharmacokinetics, efficacy, safety, and immunogenicity in 568 patients with plaque psoriasis receiving Humira or Alvotech’s AVT02 biosimilar, across 30 centers in Europe. A safety extension phase of AVT02 is scheduled to follow
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