Adalimumab biosimilar - Amgen

Drug Profile

Adalimumab biosimilar - Amgen

Alternative Names: ABP-501; Adalimumab-atto; AMJEVITA

Latest Information Update: 28 Dec 2016

Price : $50

At a glance

  • Originator Amgen
  • Class Anti-inflammatories; Anti-TNF monoclonal antibodies; Antipsoriatics; Antirheumatics
  • 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

  • Registered Ankylosing spondylitis; Crohn's disease; Juvenile rheumatoid arthritis; Plaque psoriasis; Psoriatic arthritis; Rheumatoid arthritis; Ulcerative colitis

Most Recent Events

  • 15 Oct 2016 Biosimilar data from functional studies of ABP 501, adalimumab sourced from the USA and European Union in inflammatory bowel diseases presented at the 24th United European Gastroenterology Week (EGW-2016)
  • 23 Sep 2016 Registered for Ulcerative colitis, Psoriatic arthritis, Juvenile rheumatoid arthritis, Crohn's disease, Ankylosing spondylitis, Plaque psoriasis and Rheumatoid arthritis in USA (SC)
  • 13 Jul 2016 Adalimumab biosimilar licensed to Daiichi Sankyo for commercialization in Japan
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