Adalimumab biosimilar (Solymbic) - Amgen

Drug Profile

Adalimumab biosimilar (Solymbic) - Amgen

Alternative Names: Solymbic

Latest Information Update: 23 Mar 2018

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At a glance

  • Originator Amgen
  • Class Anti-inflammatories; Anti-TNF monoclonal antibodies; Antipsoriatics; Antirheumatics; Skin disorder therapies
  • 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

  • Registered 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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