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AboutInfliximabWhat is infliximabInflammatory Bowel DiseaseMaximising patient outcomes with IBDBiosimilarsWhat is a biosimilarFuture of biosimilarsBiologic switchingINFLECTRA® Introducing INFLECTRA® Position statementsECCOEULARESPGHANDosing & safetyDosingIV dosingAdministration & storageAdministrationStorageSafety informationImportant safety informationConsiderations for SwitchingSwitching to InflectraSafety informationImportant safety informationSafety informationSafety informationClinical evidenceRandomised controlled trial evidenceSummary: randomised controlled trial evidenceReal-world experienceSummary: real-world evidenceSupporting ResourcesVideosMaterialsPatient Support


Inflectra®(infliximab) Prescribing Information. Adverse events reporting information can be found at the bottom of the page.

 


INFLECTRA® (CT-P13*/infliximab) was first infliximab infusion licensed in the EU1
  • More than 7 years of clinical experience1
     
  • Approved in more than 80 countries2
     
  • Approved across all of the same populations as Remicade™, including 2 paediatric populations3,4
     
    • 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 first approved biosimilar of infliximab infusion therapy1

Evidence

INFLECTRA® infusion therapy has been evaluated across a range of studies5-8

Resources

Pfizer provides a wealth of resources to support both patients and healthcare providers

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 Commission licence for all of the same clinical indications as Remicade™.1,3,9 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.”1,9Remicade™ is a registered trademark of MSD.AS, Ankylosing spondylitis; mAb, Monoclonal antibody; RA, Rheumatoid arthritis.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 February 2021.Yoo DH. Expert Rev Clin Immunol 2017;13(7):653-66.INFLECTRA® Summary of Product Characteristics.Remicade™ Summary of Product Characteristics.Byong Duk Y, et al. Lancet 2019;393:1699-707.Strik AS, et al. Lancet Gastroenterol Hepatol 2018;3:404-12.Armuzzi A, et al. Inflamm Bowel Dis 2019;25:568-79.Hlavaty T, et al. Gastroenterol Hepatol 2016;70:27-36.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 February 2021.
PP-IFA-GBR-0605. April 2023

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search 

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Adverse events should also be reported to Pfizer Medical Information on 01304 616161

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