Infliximab biosimilar - Nichiiko Pharmaceutical/Aprogen

Drug Profile

Infliximab biosimilar - Nichiiko Pharmaceutical/Aprogen

Alternative Names: GS 071; NI-071

Latest Information Update: 11 Oct 2018

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At a glance

  • Originator Aprogen; Nichiiko Pharmaceutical
  • Class Anti-inflammatories; Anti-TNF monoclonal antibodies; Antipsoriatics; Antirheumatics
  • Mechanism of Action 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

  • Marketed Crohn's disease; Psoriasis; Rheumatoid arthritis; Ulcerative colitis

Most Recent Events

  • 11 Oct 2018 Nichiiko Pharmaceutical announces intention to submit BLA to US FDA in 2019
  • 30 Nov 2017 Launched for Rheumatoid arthritis in Japan (IV)
  • 08 Dec 2016 Nichiiko Pharmaceutical plans the phase III RADIANCE trial for Rheumatoid arthritis (Adjunctive treatment) in Czech Republic, Poland, Russia, Spain, Ukraine, USA and United Kingdom (IV) (NCT02990806)
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