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Ustekinumab biosimilar - DM Bio

Drug Profile

Ustekinumab biosimilar - DM Bio

Alternative Names: DA 3115; DMB 3115

Latest Information Update: 11 Jan 2024

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At a glance

  • Originator Dong-A Socio Holdings; Dong-A ST; Meiji Seika Pharma
  • Developer Dong-A Socio Holdings; Meiji Seika Pharma
  • Class Anti-inflammatories; Antipsoriatics; Antirheumatics; Antiulcers; Monoclonal antibodies; Skin disorder therapies
  • Mechanism of Action Interleukin 12 inhibitors; Interleukin 23 inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No
  • Available For Licensing Yes - Psoriasis

Highest Development Phases

  • Preregistration Plaque psoriasis
  • Phase III Crohn's disease; Psoriatic arthritis; Ulcerative colitis

Most Recent Events

  • 05 Jan 2024 US FDA accepts BLA application for review for Ustekinumab biosimilar in Plaque psoriasis
  • 04 Jan 2024 Accord Biopharma announces intention to launch ustekinumab biosimilar for Plaque psoriasis in the US prior to May 15, 2025
  • 09 Oct 2023 Preregistration for Plaque psoriasis in USA (SC)
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