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A Randomized, Double-blind, Multicenter Study to Demonstrate Equivalent Efficacy and to Compare Safety and Immunogenicity of a Biosimilar Ustekinumab (AVT04) and Stelara in Patients With Moderate to Severe Chronic Plaque-type Psoriasis

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A Randomized, Double-blind, Multicenter Study to Demonstrate Equivalent Efficacy and to Compare Safety and Immunogenicity of a Biosimilar Ustekinumab (AVT04) and Stelara in Patients With Moderate to Severe Chronic Plaque-type Psoriasis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 16 Jan 2024

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At a glance

  • Drugs Ustekinumab (Primary)
  • Indications Plaque psoriasis
  • Focus Registrational; Therapeutic Use
  • Sponsors Alvotech

    • Most Recent Events

    • 10 Jan 2024 According to a Alvotech media release, In Feb 2023, company announced that the EMA had accepted their MAA for AVT04, based on a comprehensive package of analytical and clinical data, included data from the this trial and Stelara in patients with moderate to severe chronic plaque-type psoriasis. Pharmacokinetic similarity was demonstrated in the AVT04-GL-101 study.
    • 10 Jan 2024 According to a Alvotech media release, The European Commissions decision to issue a marketing authorization came after the Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agencys (EMA) in November 2023 adopted a positive opinion on approving Uzpruvo with the indications Crohns disease, psoriasis and psoriatic arthritis.
    • 10 Jan 2024 According to a Alvotech media release, the European Commission issued a marketing authorization for Uzpruvo (AVT04). Approval for the Uzpruvo biosimilar is based on comprehensive package comprising analytical, non-clinical and clinical similarity data, including the AVT04-GL-301 confirmatory comparative efficacy and safety clinical trial in patients with moderate to severe chronic plaque-type psoriasis.
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