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A Randomized, Double-Blind, Multicentric, Parallel Group Therapeutic Equivalence Study Comparing Efficacy, Safety and Immunogenicity of Subcutaneous DMB-3115 and Stelara in Patients With Moderate to Severe Chronic Plaque Psoriasis

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Trial Profile

A Randomized, Double-Blind, Multicentric, Parallel Group Therapeutic Equivalence Study Comparing Efficacy, Safety and Immunogenicity of Subcutaneous DMB-3115 and Stelara in Patients With Moderate to Severe Chronic Plaque Psoriasis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 16 Oct 2024

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At a glance

  • Drugs Ustekinumab (Primary)
  • Indications Plaque psoriasis
  • Focus Registrational; Therapeutic Use
  • Acronyms Opportuniti
  • Sponsors Dong-A ST

    • Most Recent Events

    • 11 Oct 2024 According to Dong A Socio Holdings media release, the company announced on October 11 that Imuldosa(ustekinumab-srlf/DMB-3115), a biosimilar referencing Stelara, has won U.S. Food and Drug Administration (FDA) approval.
    • 05 Jan 2024 According to Intas Pharmaceuticals media release, Dong-A ST announced that Accord BioPharma, Inc., in the USA has received a notification that the US FDA has accepted its Biologics License Application for DMB-3115 for substantive review. The BLA was submitted to the FDA by Accord BioPharma on October 9, 2023.
    • 14 Jul 2023 According to an Accord Healthcare media release, based on results from this trial, the European Medicine Agency (EMA) confirmed acceptance of Marketing Authorization Application (MAA) for DMB-3115, a biosimilar of Stelara (Ustekinumab).

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