Adalimumab biosimilar (Solymbic) - Amgen

Drug Profile

Adalimumab biosimilar (Solymbic) - Amgen

Alternative Names: Solymbic

Latest Information Update: 06 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

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

Most Recent Events

  • 01 Feb 2017 Preregistration for Juvenile rheumatoid arthritis (Treatment-experienced) in European Union (Parenteral)
  • 26 Jan 2017 The Committee for Medicinal Products for Human Use (CHMP) recommends approval of adalimumab biosimilar for rheumatoid arthritis, Juvenile rheumatoid arthritis, Ankylosing spondylitis, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn’s disease, ulcerative colitis and uveitis
  • 01 Jan 2017 Preregistration for Ankylosing spondylitis (Treatment-experienced) in European Union (Parenteral)
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