Adalimumab biosimilar - Amgen

Drug Profile

Adalimumab biosimilar - Amgen

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

Latest Information Update: 17 Feb 2017

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
  • Preregistration Hidradenitis suppurativa

Most Recent Events

  • 27 Jan 2017 The Committee for Medicinal Products for Human Use (CHMP) recommends approval of adalimumab biosimilar for rheumatoid arthritis, psoriatic arthritis, severe ankylosing spondylitis, severe axial spondyloarthritis, chronic plaque psoriasis, hidradenitis suppurativa, Crohn's disease and ulcerative colitis in European Union
  • 11 Nov 2016 Efficacy, adverse events and immunogenicity data from a phase III extension trial in Rheumatoid arthritis presented at 80th American College of Rheumatology and the 51st Annual Meeting of the Association of Rheumatology and Health Professionals
  • 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)
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