Adalimumab biosimilar - Samsung Bioepis

Drug Profile

Adalimumab biosimilar - Samsung Bioepis

Alternative Names: Imraldi; SB-5

Latest Information Update: 27 Jun 2017

Price : $50

At a glance

  • Originator Samsung Bioepis
  • 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.

  • New Molecular Entity No

Highest Development Phases

  • Preregistration Ankylosing spondylitis; Crohn's disease; Hidradenitis suppurativa; Juvenile rheumatoid arthritis; Plaque psoriasis; Psoriatic arthritis; Rheumatoid arthritis; Spondylarthritis; Ulcerative colitis; Uveitis

Most Recent Events

  • 23 Jun 2017 Biogen receives a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the EMA for adalimumab biosimilar referencing Humira®
  • 11 Nov 2016 Updated efficacy and adverse events data from a phase III trial in Rheumatoid Arthritis presented at the 80th American College of Rheumatology and the 51st Annual Meeting of the Association of Rheumatology and Health Professionals (ACR/ARHP-2016)
  • 17 Jul 2016 Preregistration for Rheumatoid arthritis (In the elderly, In adults) in European Union (SC) before July 2016
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