Etanercept biosimilar - Sandoz

Drug Profile

Etanercept biosimilar - Sandoz

Alternative Names: Erelzi; GP 2015

Latest Information Update: 09 Dec 2016

Price : $50

At a glance

  • Originator Sandoz
  • Class Antirheumatics; Disease-modifying antirheumatics; Recombinant fusion proteins
  • Mechanism of Action Immunosuppressants; 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 No

Highest Development Phases

  • Registered Ankylosing spondylitis; Juvenile rheumatoid arthritis; Plaque psoriasis; Psoriatic arthritis; Rheumatoid arthritis

Most Recent Events

  • 30 Sep 2016 The New Jersey District Court entered a preliminary injunction prohibiting Sandoz from making, using, importing, selling or offering for sale of Sandoz’s etanercept biosimilar (Amgen 10-Q, September 2016)
  • 30 Aug 2016 Registered for Rheumatoid arthritis, Psoriatic arthritis, Juvenile rheumatoid arthritis and Ankylosing spondylitis in USA (SC)
  • 13 Jul 2016 The US FDA Arthritis Advisory Committee recommends approval of etanercept biosimilar for Ankylosing spondylitis, Juvenile rheumatoid arthritis, Plaque psoriasis, Psoriatic arthritis and Rheumatoid arthritis
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