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Switching to biosimilar infliximab in IBD patients Posted 24/11/2017

Biological agents, such as infliximab, have transformed the outcomes of patients with immune-mediated inflammatory diseases. The advent of biosimilar treatment options, such as CT‑P13 (Remsima/Inflectra), promises to improve the availability of biological therapy.

CT‑P13 was authorized by the European Medicines Agency (EMA) in 2013 for several indications, including inflammatory bowel disease (IBD) [1], based on two pivotal clinical trials in patients with rheumatoid arthritis (RA) and ankylosing spondylitis (AS). The efficacy and pharmacokinetic equivalence of CT‑P13 and infliximab reference product were demonstrated in these two randomized trials at 30 weeks; and safety profiles were comparable for both infliximab formulations [2, 3]. Results up to week 54 demonstrated continued comparability between CT‑P13 and its reference product (Johnson & Johnson/Merck’s Remicade) in both patient populations [4, 5].

Based on extensive in vitro characterization through a comparability exercise and initial clinical data, the indications of CT-P13 have been extended since 2013 by EMA and more recently by the US Food and Drug Administration (FDA) and Health Canada, to include IBD [6].

Until data from randomized controlled trials in Crohn’s disease (CD) and ulcerative colitis (UC) are available, results from ‘real-world’ clinical use of the biosimilar can offer valuable insights into its efficacy and safety. For this reason, author Argüelles-Arias and colleagues from the Hospital Universitario Virgen Macarena and the University of Seville in Spain carried out an observational study assessing the efficacy and safety of switching from Remicade to CT‑P13 in patients with IBD for up to 12 months [7].

The results showed that switching from Remicade to CT-P13 is, according to the authors, ‘efficacious and well tolerated in patients with CD or UC for up to 12 months’.

These results are also in accordance with other studies, which found Remsima/Inflectra to be safe and effective in the treatment of IBD [8], also when switched from Remicade to the biosimilar [9].

A more detailed summary of the study carried out by Federico Argüelles-Arias and colleagues can be found in the article that follows.

Conflict of interest
Several of the authors of the research paper [7] reported conflict of interest, including having received honoraria from Sandoz for speaking at educational events, congress presentations and attending advisory boards. For full details of the authors’ conflict of interest, see the research paper [7].

Abstracted by Maria Fernanda Guerra Veloz, Department of Gastroenterology, Hospital Universitario Virgen Macarena, Seville, Spain.

Related article
Switching from reference infliximab to CT P13 in IBD patients

References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Nov 24]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
2. Yoo DH, Hrycaj P, Miranda P, Ramiterre E, Piotrowski M, Shevchuk S, 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.
3. Park W, Hrycaj P, Jeka S, Kovalenko V, Lysenko G, Miranda P, 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.
4. Yoo DH, Racewicz A, Brzezicki J, Yatsyshyn R, Arteaga ET, Baranauskaite A, et al. A phase III randomized study to evaluate the efficacy and safety of CT-P13 compared with reference infliximab in patients with active rheumatoid arthritis: 54-week results from the PLANETRA study.Arthritis Res Ther.2016;18:82.
5. Park W, Yoo DH, Jaworski J, Brzezicki J, Gnylorybov A, Kadinov V, et al. Comparable long-term efficacy, as assessed by patient-reported outcomes, safety and pharmacokinetics, of CT-P13 and reference infliximab in patients with ankylosing spondylitis: 54-week results from the randomized, parallel-group PLANETAS study.Arthritis Res Ther.2016;18:25.
6. GaBI Online - Generics and Biosimilars Initiative. Health Canada approves Inflectra biosimilar for extra indications [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Nov 24]. Available from: www.gabionline.net/Biosimilars/News/Health-Canada-approves-Inflectra-biosimilar-for-extra-indications
7. Argüelles-Arias F1, Guerra Veloz MF, Perea Amarillo R, Vilches-Arenas A, Castro Laria L, Maldonado Pérez B, et al. Switching from reference infliximab to CT-P13 in patients with inflammatory bowel disease: 12 months results. Eur J Gastroenterol Hepatol. 2017;29(11):1290-5.
8. GaBI Online - Generics and Biosimilars Initiative. Biosimilar infliximab safe and effective in IBD [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Nov 24]. Available from: www.gabionline.net/Biosimilars/Research/Biosimilar-infliximab-safe-and-effective-in-IBD
9. GaBI Online - Generics and Biosimilars Initiative. Post-marketing experience with IBD biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Nov 24]. Available from: www.gabionline.net/Biosimilars/Research/Post-marketing-experience-with-IBD-biosimilars

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