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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: 02 Sep 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

  • 22 Aug 2025 Bio-Thera Solutions and STADA Arzneimittel AG agreed to extend their biosimilars alliance to include Tocilizumab, for the treatment of inflammatory conditions, in the European Union, the UK, Switzerland, and selected other countries
  • 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)

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