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Ustekinumab biosimilar - Bio-Thera Solutions

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Drug Profile

Ustekinumab biosimilar - Bio-Thera Solutions

Alternative Names: BAT-2206; STARJEMZA; ustekinumab-hmny; USYMRO

Latest Information Update: 18 Sep 2025

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At a glance

  • Originator Bio-Thera Solutions
  • 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 - Autoimmune disorders

Highest Development Phases

  • Registered Crohn's disease; Plaque psoriasis; Psoriatic arthritis; Ulcerative colitis
  • No development reported Autoimmune disorders

Most Recent Events

  • 16 Sep 2025 Gedeon Richter plans to launch Ustekinumab biosimilar in European union
  • 26 Aug 2025 Registered for Plaque psoriasis in Liechtenstein, Iceland, Norway, European Union (SC)
  • 20 Jun 2025 Bio-Thera Solutions receives positive opinion from the Committee for Medicinal Products for Human Use (CHMP) recommending approval of ustekinumab biosimilar for Plaque psoriasis

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