Adalimumab biosimilar - Fujifilm Kyowa Kirin Biologics

Drug Profile

Adalimumab biosimilar - Fujifilm Kyowa Kirin Biologics

Alternative Names: FKB-327

Latest Information Update: 27 Jul 2016

Price : $50

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
  • 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.

    No
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity No

Highest Development Phases

  • Phase III Rheumatoid arthritis

Most Recent Events

  • 18 Jul 2016 Fujifilm Kyowa Kirin Biologics completes a phase III trial for Rheumatoid arthritis in the US, Canada, Germany, Spain, Bulgaria, Chile, Czech Republic, Peru, Romania, Russia, Poland and Ukraine (NCT02260791)
  • 07 Apr 2015 Fujifilm Kyowa Kirin Biologics plans a phase III trial in Rheumatoid arthritis in USA, Canada, Czech Republic, Russia and Spain (NCT02405780)
  • 01 Jan 2015 Phase-III clinical trials in Rheumatoid arthritis in Germany, Spain (SC) (EudraCT2014-000109-11)
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