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Alvotech Initiates AVT04-GL-301 Study of AVT04 Proposed Biosimilar to Stelara (ustekinumab) for the Treatment of Plaque Psoriasis

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Alvotech Initiates AVT04-GL-301 Study of AVT04 Proposed Biosimilar to Stelara (ustekinumab) for the Treatment of Plaque Psoriasis

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  • The first patient has been dosed in the comparative- confirmatory efficacy- and safety AVT04-GL-301 clinical study to evaluate AVT04 vs Stelara in ~ 530 patients with plaque psoriasis across five countries in the EU
  • The purpose of the study is to demonstrate therapeutic equivalence b/w AVT04 and Stelara in terms of safety- efficacy- and immunogenicity
  • Additionally- the company is also conducting an AVT04-GL-101- PK similarity study to assess equivalent PK endpoints- safety and tolerability for AVT04 in ~ 294 healthy adult volunteers across Australia and New Zealand

  Ref: Businesswire | Image: Alvotech

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