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A Review of CT-P13: An Infliximab Biosimilar

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Abstract

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.

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Disclosure

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.

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Correspondence to Kate McKeage.

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The manuscript was reviewed by: M. T. Nurmohamed, Rheumatology and Internal Medicine, VU University Medical Center & Reade, Amsterdam Rheumatology Immunology Center, Amsterdam, The Netherlands; D. L. Scott, Department of Rheumatology, Kings College London School of Medicine, London, UK; D. H. Yoo, Division of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Department of Internal Medicine Hanyang University College of Medicine, Seoul, Republic of Korea.

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McKeage, K. A Review of CT-P13: An Infliximab Biosimilar. BioDrugs 28, 313–321 (2014). https://doi.org/10.1007/s40259-014-0094-1

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