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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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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: 24 Dec 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

    • 19 Dec 2024 According to Dong-A ST media release, has received marketing authorization from the European Commission (EC) as of December 18 for IMULDOSA (Stelara biosimilar).
    • 21 Oct 2024 According to Accord Healthcare media release, biosimilar IMULDOSA (active ingredient: ustekinumab, development code DMB-3115), referencing Stelara, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA).
    • 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.

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