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Click here for Inflectra® (infliximab) Prescribing Information. Adverse event reporting information can be found at the bottom of the page.

Title

Inflectra is indicated in moderate to severe Crohn’s disease, moderate to severe ulcerative colitis, active rheumatoid arthritis, severe active ankylosing spondylitis, active progressive psoriatic arthritis, and moderate to severe plaque psoriasis

Introducing inflectra / CT-P13* (infliximab)

Inflectra/CT-P13* (infliximab) is the first approvedठbiosimilar 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 clinical 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’s mechanism of action

What the innovative mechanism of action for Pfizer Infectra

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All you need to know about switching

Why switch? Hear what KOLs have to say about the advantanges of switiching

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Read about the evidence in Inflectra

Read the clinical evidence supporting the use of Inflectra across indications

Explore the evidence

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What is a biosimilar?

Find out more information on what a biosimilar is and how they can help optimise treatment within the NHS

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Optimising treatment with infectra

Learn more about TDM and biomarkers with Inflectra across indications

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*CT-P13 is marketed under different brand names including INFLECTRA and REMSIMA®.

‡INFLECTRA has demonstrated comparable efficacy and safety to Remicade® in rigorous clinical studies for RA and AS and, via extrapolation, is licensed for all the same clinical indications as Remicade®.1-3

§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”.1,3

†Remicade® is a registered trademark of MSD.
EMA=European Medicines Agency; mAb=Monoclonal antibody RA, Rheumatoid arthritis; AS, Ankylosing spondylitis; TDM, Therapeutic drug monitoring.
References
  1. European Public Assessment Report: Inflectra [online]. 2013[viewed: February 2021]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR__Public_assessment_report/human/002778/WC500151490.pdf
  2. Inflectra Summary of Product Characteristics. 
  3. European Medicines Agency. Guidelines on Similar Biological Medicinal Products Containing Monoclonal Antibodies -Non-Clinical and Clinical Issues [online]. 2012[viewed: February 2021].Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500128686.pdf
  4. IQVIA Cumulative Sales Data. April 2018.
  5. Danese S, et al. Aliment PharmacolTher. 2011. 33:857-69.
  6. Moss AC. Gastroenterol Rep. 2015. 3(1):63-68.
  7. 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.htm
  8. EMA. 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-infections
  9. Medscape. [online]. 2005 [viewed: February 2021]. Available from: https://www.medscape.com/viewarticle/513282
  10. EMA. Remicade Scientific Discussion. 2006.
  11. Centocor, Inc. [online]. 2007 [viewed: February 2021]. Available from: https://www.eurekalert.org/pub_releases/2007-11/ci-rbf110607.php
  12. Remicade® (infliximab). [online]. 2017 [viewed: February 2021].Available from: www.remicade.com
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