A Review of CT-P13: An Infliximab Biosimilar
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CT-P13 (Remsima™; Inflectra™), a biosimilar of reference infliximab (Remicade®), is approved by the European Medicines Agency 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. Infliximab is a chimeric human-murine monoclonal antibody against the proinflammatory cytokine tumour necrosis factor-α. The CT-P13 infliximab formulation is identical to that of reference infliximab and it has similar physiochemical characteristics. The approval of CT-P13 was based on the results of a rigorous, comparability exercise. This article reviews the results of that exercise, focusing on the clinical evaluation programme. In two well-designed clinical trials, CT-P13 was equivalent to reference infliximab in terms of pharmacokinetic properties in patients with ankylosing spondylitis and in terms of efficacy in patients with rheumatoid arthritis. In both studies, CT-P13 was generally well tolerated with a similar tolerability profile to that of reference infliximab. Immunogenicity evaluations demonstrated that the proportion of patients developing anti-drug antibodies was similar with each agent. Preliminary data from trial extensions demonstrated that in patients who switched from reference infliximab to CT-P13, efficacy was sustained and similar to those who were treated continuously with CT-P13. As with all biosimilar and generic agents, CT-P13 has the potential to reduce treatment costs compared with those of reference infliximab, and modelled analyses predict significant cost savings compared with reference infliximab. In conclusion, CT-P13 is an infliximab biosimilar that provides a useful alternative to reference infliximab in patients requiring infliximab therapy.
The preparation of this review was not supported by any external funding. During the peer review process, the manufacturer of the agent under review was offered an opportunity to comment on this article. Changes resulting from comments received were made by the author on the basis of scientific and editorial merit.
- 1.World Health Organization. Guidelines on evaluation of similar biotherapeutic products (SBPs); 2009. http://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf. Accessed 19 Dec 2013.
- 2.European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP). Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. Draft; 2013. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/06/WC500144124.pdf. Accessed 17 Feb 2014.
- 3.European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP). Assessment report: Inflectra (infliximab); 2013. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002778/WC500151490.pdf. Accessed 17 Feb 2014.
- 6.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.PubMedCentralPubMedCrossRefGoogle Scholar
- 7.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.PubMedCentralPubMedCrossRefGoogle Scholar
- 8.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]. 14th Annual Congress of the European League Against Rheumatism, Madrid; 12–15 Jun 2013.Google Scholar
- 9.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]. 14th Annual Congress of the European League Against Rheumatism, Madrid; 12–15 Jun 2013.Google Scholar
- 10.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]. ACR/ARHP Annual Meeting, San Diego; 26–30 Oct 2013.Google Scholar
- 11.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]. ACR/ARHP Annual Meeting, San Diego; 26–30 Oct 2013.Google Scholar
- 12.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]. ACR-ARHP Annual Meeting, San Diego; 26–30 Oct 2013.Google Scholar
- 14.Putrik P, Ramiro S, Kvien TK, et al. Variations in criteria regulating treatment with reimbursed biologic DMARDs across European countries. Are differences related to country’s wealth? Ann Rheum Dis. 2013. doi: 10.1136/annrheumdis-2013-203819.
- 17.European Medicines Agency. Remsima: summary of product characteristics; 2013. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002576/WC500150871.pdf. Accessed 19 Dec 2013.
- 18.European Medicines Agency. Inflectra: summary of product characteristics; 2013. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002778/WC500151489.pdf. Accessed 19 Dec 2013.
- 20.US Food and Drug Administration. Quality considerations in demonstrating biosimilarity to a reference protein product: draft guidance; 2012. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm291134.pdf. Accessed 13 Jan 2014.
- 27.Antoni CE, Kavanaugh A, Kirkham B, et al. Sustained benefits of infliximab therapy for dermatologic and articular manifestations of psoriatic arthritis: results from the infliximab multinational psoriatic arthritis controlled trial (IMPACT). Arthritis Rheum. 2005;52(4):1227–36.PubMedCrossRefGoogle Scholar