Infliximab biosimilar - Merck & Co/Samsung Bioepis

Drug Profile

Infliximab biosimilar - Merck & Co/Samsung Bioepis

Alternative Names: Flixabi; Infliximab - Samsung Bioepis; RENFLEXIS; SB 2

Latest Information Update: 17 Feb 2017

Price : $50

At a glance

  • Originator Samsung Bioepis
  • Class Anti-inflammatories; Anti-TNF monoclonal antibodies; Antipsoriatics; Antirheumatics
  • Mechanism of Action Tumour necrosis factor 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 Yes

Highest Development Phases

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

Most Recent Events

  • 24 Jan 2017 Biogen and Ewopharma signs a distribution agreement to market and sell etanercept and infliximab in Romania, Bulgaria, Croatia, Estonia, Latvia and Lithuania
  • 11 Nov 2016 Immunogenicity, efficacy and adverse events data from a phase III trial for Rheumatoid arthritis was presented at the 80th American College of Rheumatology and the 51st Annual Meeting of the Association of Rheumatology and Health Professionals (ACR/ARHP - 2016)
  • 09 Jun 2016 Efficacy and adverse events data from a phase III trial in Rheumatoid arthritis presented at the 17th Annual Congress of the European League Against Rheumatism (EULAR-2016)
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