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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; Shireli; Tocilizumab-bavi; TOFIDENCE; TOFIDENCETM

Latest Information Update: 13 Jul 2026

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At a glance

  • Originator Bio-Thera Solutions
  • Developer Bio-Thera Solutions; Biogen; Organon
  • 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; Giant cell arteritis; Juvenile rheumatoid arthritis; Rheumatoid arthritis
  • Registered COVID 2019 infections

Most Recent Events

  • 10 Jun 2026 Registered for COVID-2019 infections (In children, In adolescents, In adults) in USA (IV, Injection)
  • 10 Jun 2026 Registered for Cytokine release syndrome (In children, In infants, In adults) in USA (IV, Injection)
  • 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

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