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AboutInfliximabWhat is infliximabMechanism of actionBiosimilarsApprovalOverviewPosition statementsECCOEULARESPGHANDosing & SwitchingDosingIV dosingAdministration & storageIV administrationStorageSafety informationImportant safety informationSwitchingConsiderations for switchingSafety informationImportant safety informationSafety informationImportant safety informationClinical EvidenceRandomised controlled trial evidenceSummary: randomised controlled trial evidenceSupport & ResourcesMaterials
INFLECTRA® (CT-P13*/infliximab) was the first infliximab infusion biosimilar approved by the EMA†1
  • Approved for use in the EU since 20131
  • Approved across all of the same populations as Remicade™,‡ including 2 paediatric populations2,3
     
    • ​​​​​​​In gastroenterology: Crohn’s disease, ulcerative colitis, paediatric Crohn’s disease and paediatric ulcerative colitis
       
    • In rheumatology: rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis
       
    • In dermatology: psoriasis
 INFLECTRA®

INFLECTRA® was the first EMA-approved biosimilar of infliximab infusion therapy1

 Evidence

INFLECTRA® infusion therapy has been evaluated across a range of studies

 Support & Resources

Pfizer has a range of resources available to support you and your patients

CT-P13 is marketed under different brand names including INFLECTRA® and REMSIMA™.INFLECTRA® (CT-P13/infliximab) infusion therapy has demonstrated comparable efficacy and safety to Remicade™ (infliximab) in rigorous clinical studies for RA and AS and, via extrapolation, has been granted a European licence for all of the same clinical indications as Remicade™.1,2,4 EMA guidelines state that “Extrapolation of clinical efficacy and safety data to other indications of the reference mAb, not specifically studied during the clinical development of the biosimilar mAb, is possible based on the results of the overall evidence provided from the comparability exercise and with adequate justification.”1,4Remicade™ is a registered trademark of MSD.AS, Ankylosing spondylitis; EMA, European Medicines Agency; mAb, Monoclonal antibody; RA, Rheumatoid arthritis.

Please refer to the INFLECTRA® Summary of Product Characteristics for full prescribing information

References:European Public Assessment Report: INFLECTRA®. 27 June 2013. Available at: http://www.ema.europa.eu/docs/en_GB/document_ library/EPAR_-_Public_assessment_report/human/002778/ WC500151490.pdf. Accessed May 2023.INFLECTRA® Summary of Product Characteristics.Remicade™ Summary of Product Characteristics.European Medicines Agency. Guidelines on similar biological medicinal products containing monoclonal antibodies – non-clinical and clinical issues. 30 May 2012. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/ 2012/06/WC500128686.pdf. Accessed May 2023.

Legal Category: S1A
Further information is available upon request

PP-IFA-IRL-0145 May 2023

Adverse events should be reported. Report an adverse event to your national reporting system (HPRA Pharmacovigilance)
 

Adverse events should also be reported to Pfizer Medical Information on 1800 633 363

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