Adalimumab biosimilar - Fujifilm Kyowa Kirin Biologics

Drug Profile

Adalimumab biosimilar - Fujifilm Kyowa Kirin Biologics

Alternative Names: FKB-327

Latest Information Update: 12 Apr 2018

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At a glance

  • Originator FUJIFILM Corporation - Kyowa Hakko Kirin (JV); Fujifilm Kyowa Kirin Biologics
  • Developer Fujifilm Kyowa Kirin Biologics
  • Class Anti-inflammatories; Anti-TNF monoclonal antibodies; Antipsoriatics; Antirheumatics; Monoclonal antibodies; Skin disorder therapies
  • Mechanism of Action Immunomodulators; Tumour necrosis factor alpha inhibitors
  • Orphan Drug Status

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

  • New Molecular Entity No

Highest Development Phases

  • Preregistration Rheumatoid arthritis

Most Recent Events

  • 11 Apr 2018 Adalimumab biosimilar market licensed to Mylan in Europe
  • 11 Apr 2018 Fujifilm Kyowa Kirin Biologics expects decision from EMA on its MAA in the second half of 2018
  • 03 Nov 2017 Efficacy data from the phase III ARABESC trial in Rheumatoid arthritis presented at the 81st American College of Rheumatology and the 52nd Association of Rheumatology Health Professionals Annual Scientific Meeting (ACR/ARHP-2017)
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