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Adalimumab biosimilar - Amgen

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Drug Profile

Adalimumab biosimilar - Amgen

Alternative Names: ABP-501; Adalimumab beta - Amgen; Adalimumab-atto - Amgen; AMGEVITA; Amgevita; Amjevita; Solymbic

Latest Information Update: 09 Dec 2025

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At a glance

  • Originator Amgen
  • Class Anti-inflammatories; Anti-TNF monoclonal antibodies; Antineoplastics; Antipsoriatics; Antirheumatics; Eye disorder therapies; Hepatoprotectants; Immunotherapies; Nootropics; Skin disorder therapies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; Immunosuppressants; 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
  • New Molecular Entity No

Highest Development Phases

  • Marketed Ankylosing spondylitis; Crohn's disease; Hidradenitis suppurativa; Juvenile rheumatoid arthritis; Plaque psoriasis; Psoriasis; Psoriatic arthritis; Rheumatoid arthritis; Ulcerative colitis; Uveitis
  • Registered Behcet's syndrome; Pustular psoriasis

Most Recent Events

  • 09 Dec 2025 Adalimumab biosimilar is registered for Ankylosing spondylitis, Pustular psoriasis, Behcet's syndrome and Plaque psoriasis (SC) in Japan
  • 09 Dec 2025 Adalimumab biosimilar is registered for Rheumatoid arthritis, Juvenile rheumatoid arthritis and Psoriatic arthritis (SC) in Japan
  • 10 Nov 2023 Interim adverse events, pharmacokinetic and immunogenicity data from a phase I pharmacokinetic trial presented at the ACR Convergence 2023 (ACR-2023)

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