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CT-P13 (an infliximab biosimilar): a guide to its use in the EU

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Abstract

CT-P13 (Remsima™; Inflectra™) is an infliximab biosimilar approved in the EU for use in all indications for which reference infliximab is approved, including rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and psoriasis. Approval of CT-P13 was based on the results of a rigorous analysis comparing CT-P13 with reference infliximab, including two well-designed clinical trials that demonstrated equivalent efficacy and pharmacokinetic profiles in patients with ankylosing spondylitis and rheumatoid arthritis. As with all biosimilar agents, CT-P13 has the potential to reduce treatment costs relative to those of reference infliximab.

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References

  1. Committee for Medicinal Products for Human Use (CHMP). Guideline on similar biological medicinal products. London: European Medicines Agency; 2014.

  2. Boone N, van der Kuy H, Scott M, et al. How to select a biosimilar. Eur J Hosp Pharm. 2013;20:275–86.

    Article  Google Scholar 

  3. Committee for Medicinal Products for Human Use (CHMP). Assessment report: Inflectra (infliximab). London: European Medicines Agency; 2013.

  4. Remsima: summary of product characteristics. London: European Medicines Agency; 2013.

  5. Inflectra: summary of product characteristics. London: European Medicines Agency; 2013.

  6. Yoo DH, Hrycaj P, Miranda P, et al. A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann Rheum Dis. 2013;72(10):1613–20.

    Article  PubMed Central  CAS  PubMed  Google Scholar 

  7. Park W, Hrycaj P, Jeka S, et al. A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study. Ann Rheum Dis. 2013;72(10):1605–12.

    Article  PubMed Central  CAS  PubMed  Google Scholar 

  8. Jung SW, Lee KH, Jeon JW, et al. Physiochemical characterization of Remsima. MAbs. 2014;6:1163–77.

    Article  PubMed  Google Scholar 

  9. Park W, Jaworski J, Brzezicki J, et al. A randomised, double-blind, parallel-group, phase 1 study comparing the pharmacokinetics, safety and efficacy of CT-P13 and infliximab in patients with active ankylosing spondylitis: 54 week results from the PLANETAS study [abstract no. FRI0421]. Ann Rheum Dis. 2013;72(Suppl 3):516.

    Article  Google Scholar 

  10. Yoo DH, Racewicz A, Brzezicki J, et al. A phase 3 randomised controlled trial to compare CT-P13 with infliximab in patients with active rheumatoid arthritis: 54 week results from the PLANETRA study [abstract no. OP0068]. Ann Rheum Dis. 2013;72(Suppl 3):73.

    Article  Google Scholar 

  11. Yoo D, Yagensky A, Toncheva A, et al. Impact of CT-P13 and originator infliximab treatment on quality of life derived from the Health Assessment Questionnaire (AQ) and Short-Form 36 (SF-36) from a randomized, double-blind trial in patients with active RA [abstract no. 2392]. In: ACR/ARHP Annual Meeting; 2013.

  12. Park W, Miranda P, Brzosko M, et al. Efficacy and safety of CT-P13 (infliximab biosimilar) over two years in patients with ankylosing spondylitis: comparison between continuing with CT-P13 and switching from infliximab to CT-P13 [abstract no. L15]. In: ACR/ARHP Annual Meeting; 2013.

  13. Yoo DH, Prodanovic N, Jaworski J, et al. Efficacy and safety of CT-P13 (infliximab biosimilar) over two years in patients with rheumatoid arthritis: comparison between continued CT-P13 and switching from infliximab to CT-P13 [abstract no. L1]. In: ACR-ARHP Annual Meeting; 2013.

  14. Sokka T, Kautianen H. Clinical experience with infliximab biosimilar: switch from Remicade [abstract no. SAT0174]. Ann Rheum Dis. 2015;74(Suppl 2):717.

    Google Scholar 

  15. Park W, Yoo DH, Suh CH, et al. Meta-analysis of the safety data between infliximab biosimilar (CT-P13) and innovator infliximab in rheumatoid arthritis and ankylosing spondylitis [abstract no. AB0433]. Ann Rheum Dis. 2015;74(Suppl 2):1039.

    Google Scholar 

  16. McCarthy G, Bitoun EC, Guy H. Introduction of an infliximab biosimilar (CT-P13): a five-year budget impact analysis for the treatment of rheumatoid arthritis in Ireland [abstract no. PMS22]. Value Health. 2013;16(7):A558.

    Article  Google Scholar 

  17. Brodszky V, Baji P, Balogh O, et al. Budget impact analysis of biosimilar infliximab (CT-P13) for the treatment of rheumatoid arthritis in six Central and Eastern European countries. Eur J Health Econ. 2014;15(Suppl 1):S65–71.

    Article  PubMed  Google Scholar 

  18. Yoo DH. The rise of biosimilars: potential benefits and drawbacks in rheumatoid arthritis. Expert Rev Clin Immunol. 2014;10:981–3.

    Article  CAS  PubMed  Google Scholar 

  19. Feagan BG, Choquette D, Ghosh S, et al. The challenge of indication extrapolation for infliximab biosimilars. Biologicals. 2014;42:177–83.

    Article  CAS  PubMed  Google Scholar 

  20. Kang Y-S, Moon HH, Lee SE, et al. Clinical experience of the use of CT-P13, a biosimilar to infliximab in patients with inflammatory bowel disease: a case series. Dig Dis Sci. 2015;60:951–6.

    Article  CAS  PubMed  Google Scholar 

  21. Jung YS, Park DI, Kim YH, et al. Efficacy and safety of CT-P13, a biosimilar of infliximab, in patients with inflammatory bowel disease: a retrospective multicenter study. J Gastroenterol Hepatol. 2015. doi:10.1111/jgh.12997.

    Google Scholar 

  22. Murphy C, Sugrue K, Mohamad G, et al. Biosimilar but not the same [poster P505]. In: European Crohn’s and Colitis Organisation (ECCO) Congress; 2015.

  23. Danese S, Gomollon F. ECCO position statement: the use of biosimilar medicines in the treatment of inflammatory bowel disease (IBD). J Crohns Colitis. 2013;7:586–9.

    Article  PubMed  Google Scholar 

  24. Kurki P, Bielsky MC. ECCO position challenged by European drug regulators. J Crohns Colitis. 2014;8:258.

    Article  PubMed  Google Scholar 

  25. McKeage K. A review of CT-P13: an infliximab biosimilar. BioDrugs. 2014;28(3):313–21.

    Article  CAS  PubMed  Google Scholar 

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Acknowledgments

This article was adapted from BioDrugs 2014;28(3):313–21 [25], and was reviewed by: F. Araujo, Faculty of Experimental Sciences, Pablo de Olavide University, Seville, Spain; R. Janknegt, Orbis Medical Centre, Sittard-Geleen, The Netherlands; M. T. Nurmohamed, Rheumatology and Internal Medicine, VU University Medical Center and Reade, Amsterdam Rheumatology Immunology Center, Amsterdam, The Netherlands; S. Saluja, Saran Ashram Hospital, Dayalbagh, Agra, India. During the peer review process, the manufacturer of CT-P13 was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.

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    Kate McKeage

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  1. Kate McKeage
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Correspondence to Kate McKeage.

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The preparation of this review was not supported by any external funding.

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Kate McKeage is a salaried employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.

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McKeage, K. CT-P13 (an infliximab biosimilar): a guide to its use in the EU. Drugs Ther Perspect 31, 296–301 (2015). https://doi.org/10.1007/s40267-015-0233-x

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