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Infliximab biosimilar - Celltrion

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Drug Profile

Infliximab biosimilar - Celltrion

Alternative Names: Anti-TNF alpha Mab; Anti-TNF alpha monoclonal antibody; CT-P13; CT-P13 IV; CT-P13 SC; Inflectra; Infliximab biosimilar - Hospira; INT-023; Remdantry; Remsima; RemsimaSC; TH-023; ZYMFENTRA

Latest Information Update: 11 Dec 2025

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At a glance

  • Originator Celltrion
  • Developer Alvogen; Celltrion; Hospira; Kern Pharma; Nippon Kayaku; Orion; Tharimmune
  • Class Anti-inflammatories; Anti-TNF monoclonal antibodies; Antipsoriatics; Antirheumatics
  • Mechanism of Action 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; Inflammatory bowel diseases; Plaque psoriasis; Psoriasis; Psoriatic arthritis; Rheumatoid arthritis; Ulcerative colitis
  • Preclinical Autoimmune disorders

Most Recent Events

  • 18 Nov 2025 European Commission approves marketing authorization for Infliximab biosimilar liquid formulation for Rheumatoid arthritis, Ankylosing spondylitis, Crohn's disease, Plaque psoriasis, Psoriatic arthritis and Ulcerative colitis (IV) in European Union
  • 08 Jul 2025 Tharimmune plans a phase I trial in Autoimmune disorders (PO) in second half of 2025
  • 27 Mar 2025 Celltrion plans to launch infliximab biosimilar in Canada

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