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Alvotech Champions Switching Data As Clock Ticks On Adalimumab Filing

Top-Line Results Announced In Major Switching Study; Bioequivalence Demonstrated

 
• By Dean Rudge
  
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Before the month is out, Alvotech hopes to hear back from the US FDA for its AVT02 high-concentration 100mg/ml biosimilar adalimumab candidate. The Icelandic firm, which remains embroiled in litigation with originator AbbVie, has reported top-line results from its key switching study. 

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Teva is to commercialize the AVT02 biosimilar • Source: Alamy

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...

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