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Introducing INFLECTRA®/CT-P13 (infliximab)

Introducing INFLECTRA®/CT-P13 (infliximab)

INFLECTRA®/CT-P13 (infliximab) is the first approved biosimilar infliximab5

  • Proven comparable efficacy and safety to Remicade™ (infliximab) in rigorous clinical studies for RA and AS5
  • Via extrapolation, granted a European Commission licence for all of the same clinical indications as Remicade™ (infliximab) §4-6

 

Watch the video to learn how infliximab blocks the functional activity of TNF-α

Learn about the clinical and real-world evidence of CT-P13 in IBD.

Clinical trial evidence in IBD

Real-world evidence in IBD

CT-P13 has >107,000 patients years of exposure across indications7

Infliximab revolutionised the management of CD and UC8,9

Infliximab is a cornerstone treatment for many inflammatory diseases – with more than 15 years of clinical experience8-15

Infliximab is recommended by ECCO guidelines16,17

 

*CT-P13 was designed with comparable efficacy, safety and quality to reference infliximab, to increase the treatment options for your Crohn’s disease and ulcerative colitis patients.5,6 Increasing real-world experience confirms the CT-P13 clinical efficacy and safety profile.18

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

‡Remicade is a registered trademark of MSD.

§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.”5,6

#Cumulative exposure from August 1998 through August 2016. Uses include rheumatoid arthritis, Crohn’s disease, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, and ulcerative colitis.

 

AS, Ankylosing spondyloarthritis; CD, Crohn’s disease; ECCO, European Crohn’s and Colitis Organisation; EMA, European Medicines Agency; IBD, Inflammatory bowel disease; mAb, Monocloncal antibody; OLE, Open-label extension; RA, Rheumatoid arthritis; RCT, Randomised clinical trial; TNFi, Tumour necrosis factor inhibitor; UC, Ulcerative colitis.

 

 

Šaltiniai: 

1. Gecse KB, et al. J Crohns Colitis 2016;10(2):133-40. 2. Jørgensen KK, et al. Lancet 2017;389:2304-16. 3. QuintilesIMS. MIDAS, February 2017. 4. INFLECTRA® Summary of Product Characteristics. 5. European Public Assessment Report: INFLECTRA®. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_asses.... Accessed December 2017. 6. European Medicines Agency. Guidelines on similar biological medicinal products containing monoclonal antibodies – non-clinical and clinical issues. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guidelin.... Accessed December 2017. 7. Yoo DH. Expert Rev Clin Immunol 2017;13(7):653-66. 8. Danese S, et al. Aliment Pharmacol Ther 2011;33:857-69.  9. Moss AC. Gastroenterol Rep 2015;3(1):63-8. 10. FDA. CBER approval letter, infliximab. 1998. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/inflcen082....
Accessed December 2017. 11. EMA. Public Statement on Remicade (infliximab). 2000. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2.... jsp&mid=WC0b01ac058004d5c1. Accessed December 2017. 12. Medscape. [Public Release: 22 September 2005]. https://www.medscape.com/viewarticle/513282. Accessed December 2017. 13. EMA. Remicade Scientific Discussion. 2006. 14. Centocor, Inc. [Public Release: 6 November 2007]. https://www.eurekalert.org/pub_releases/2007-11/ci-rbf110607.php. Accessed December 2017. 15. Remicade (infliximab). www.remicade.com. Accessed December 2017. 6. Gomollon F, et al. J Crohns Colitis 2016;1-26. 17. Dignass A, et al. J Crohns Colitis 2012;6:991-1030. 18. Danese S, et al. J Crohns Colitis 2017;11:26-34.

 

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