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Tocilizumab biosimilar - BioGen/Bio-Thera Solutions

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Drug Profile

Tocilizumab biosimilar - BioGen/Bio-Thera Solutions

Alternative Names: BAT-1806; BIIB-800; Tocilizumab-bavi; TOFIDENCE; TOFIDENCETM

Latest Information Update: 14 Apr 2025

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At a glance

  • Originator Bio-Thera Solutions
  • Developer Bio-Thera Solutions; Biogen
  • Class Anti-inflammatories; Antineoplastics; Antirheumatics; Antivirals; Immunotherapies; Monoclonal antibodies; Skin disorder therapies; Urologics; Vascular disorder therapies
  • Mechanism of Action Interleukin 6 receptor antagonists
  • 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

Highest Development Phases

  • Marketed Cytokine release syndrome; Juvenile rheumatoid arthritis; Rheumatoid arthritis
  • Registered COVID 2019 infections
  • Phase III Giant cell arteritis

Most Recent Events

  • 01 Apr 2025 Organon acquires regulatory and commercial rights for tocilizumab biosimilar from Biogen in USA
  • 26 Sep 2024 Biogen completes a phase I trial in volunteers in the USA and United Kingdom (SC) (NCT06262477)
  • 24 Jun 2024 Registered for COVID-2019 infections in European Union (IV)

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