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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 evidenceResourcesHCP & Patient video resourcesHCP & Patient material resourcesPatient Support


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

 

Introducing INFLECTRA® (CT-P13*/infliximab)

Inflectra/CT-P13* (infliximab) is an approved‡§ biosimilar infliximab.1
 

Demonstrated comparable efficacy and safety profile to Remicade®† in rigorous clinical studies for RA and AS.1-3
 

Via extrapolation, Inflectra is licensed for all of the same therapeutic indications as Remicade®.§,1-3
 

CT-P13* has more than 370,000 patients years of exposure across indications.4
 

Infliximab is a cornerstone treatment for many inflammatory diseases – with more than 15 years of clinical experience across all indications.5-12

INFLECTRA is indicated for the treatment of:Only the IV formulation of infliximab is licensed for paediatric CD and UC3,4​​​​​​​

Return to our Inflectra homepage to explore more about Infliximab 

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 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.”1,3Remicade™ is a registered trademark of MSD.AS, Ankylosing spondylitis; CD, Crohn’s disease; mAb, Monoclonal antibody; PsA, Psoriatic arthritis; PsO, Psoriasis; RA, Rheumatoid arthritis; UC, Ulcerative colitis.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 March 2021.INFLECTRA® Summary of Product Characteristics.Guidelines on similar biological medicinal products containing monoclonal antibodies - Non-Clinical Issues [online]. 2012 [viewed: February 2021]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/scientific_guideline/2012/06/WC500128686.pdfIQVIA Cumulative Sales Data. April 2018.Danese S, et al. Aliment PharmacolTher. 2011. 33:857-69Moss AC. Gastroenterol Rep. 2015. 3(1):63-68.FDA. CBER approval letter, infliximab FDA. CBER approval letter, infliximab [online]. 1998[viewed: February 2021]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/inflcen082498L.htmEMA. Public Statement on Remicade® (infliximab).[online]. 2000 [viewed: February 2021] Available at: https://www.ema.europa.eu/en/news/public-statement-remicade-infliximab-reports-tuberculosis-infectionsMedscape [online]. 2005 [viewed: February 2021] Available from@ https://medscape.com/viewarticle/513282EMA. Remicade Scientific Discussion. 2006Centocor, Inc. [Online]. 2007 [viewed: February 2021]. Available from: https://www.eurekalert.org/pub_releases/2007-11/ci-rbf110607.phpRemicade™ Summary of Product Characteristics.
INFLECTRA®
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Learn more about Infliximab & important safety information
PP-IFA-GBR-0606. April 2023

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

for MHRA Yellow Card in Google Play or Apple App Store

 

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

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