US-based generics maker Hospira presented preliminary results from its Hungarian National Registry study for its infliximab biosimilar Inflectra at the European Crohn’s and Colitis Organisation Inflammatory Bowel Diseases (ECCO-ibd) conference, which was held in Barcelona, Spain on 18–21 February 2015.
Preliminary results presented from the ongoing independent, prospective, nationwide study in Hungary show that for the first 90 patients, [57 with Crohn’s disease (CD) and 33 with ulcerative colitis (UC)] treated with Inflectra, reductions compared with baseline were seen in validated measures of disease activity after both two and six weeks of treatment [1]. C-reactive protein (CRP), a marker of inflammation, was also decreased during induction therapy for UC. Four of the 90 patients showed an allergic reaction to treatment, all of whom had previously received anti-tumour necrosis factor (TNF) medication.
The study will follow individual patients with CD for a period of 108 weeks, and patients with UC for a period of 54 weeks, following treatment with Inflectra.
Inflectra (infliximab), the first monoclonal antibody biosimilar, was approved in the European Union (EU) in September 2013 [2]. In the EU, Korea and Japan, all indications of the originator product Remicade, including ankylosing spondylitis, rheumatoid and psoriatic arthritis, psoriasis and inflammatory bowel diseases (IBD: CD and UC) were approved [2-4]. However, in Canada extrapolation from autoimmune arthritis to IBD was not granted [5]. Other groups have also questioned the extrapolation to IBD [6, 7], despite the fact that the European Medicines Agency has defended its decision to approve Inflectra in extrapolated indications and has presented scientific arguments to support the extrapolation [8].
Results of a survey carried out by ECCO also reported that most respondents (63.7%) would not switch a patient onto a biosimilar monoclonal antibody, as there is no disease-specific evidence about their interchangeability [9].
In total data assessing the use of biosimilar infliximab (CT-P13) in IBD in 272 patients was presented as abstracts at the ECCO-ibd conference.
Another abstract presented at ECCO-ibd by Kim et al. reported that the introduction of biosimilar infliximab for the treatment of CD alone could lead to savings of between Euros 76 million and Euros 336 million across the UK, Italy and France within five years [10].
*Extrapolation involves extending and applying the data from clinical studies regarding one medical condition to another medical condition.
Conflict of interest
The authors of abstract [1] did not provide the conflict of interest statement. The authors of abstract [10] are employees of Celltrion.
Editor’s comment
It should be noted that data of the study presented in this article were published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
Related articles
Remsima shows comparable safety and efficacy in IBD patients
Infliximab biosimilar comparable to Remicade
References
1. Gecse K, Farkas K, Lovasz B, et al. P314 Biosimilar infliximab in inflammatory bowel diseases: first interim results from a prospective nationwide observational cohort. Poster presentations: Clinical: Therapy & observation (2015). ECCO 2015, Barcelona, Spain; 18-21 February 2015.
2. GaBI Online - Generics and Biosimilars Initiative. EC approves first monoclonal antibody biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jun 12]. Available from: www.gabionline.net/Biosimilars/News/EC-approves-first-monoclonal-antibody-biosimilar
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in South Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jun 12]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-South-Korea
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilar infliximab receives approval in Japan and Turkey [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jun 12]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-infliximab-receives-approval-in-Japan-and-Turkey
5. GaBI Online - Generics and Biosimilars Initiative. Subsequent entry biologics approved in Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jun 12]. Available from: www.gabionline.net/Biosimilars/General/Subsequent-entry-biologics-approved-in-Canada
6. GaBI Online - Generics and Biosimilars Initiative. Extrapolation of biosimilar infliximab indications to inflammatory bowel disease [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jun 12]. Available from: www.gabionline.net/Biosimilars/Research/Extrapolation-of-biosimilar-infliximab-indications-to-inflammatory-bowel-disease
7. GaBI Online - Generics and Biosimilars Initiative. ABPI issues updated position paper on biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jun 12]. Available from: www.gabionline.net/Biosimilars/General/ABPI-issues-updated-position-paper-on-biosimilars
8. GaBI Online - Generics and Biosimilars Initiative. Extrapolation of indications in biosimilars: infliximab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jun 12]. Available from: www.gabionline.net/Biosimilars/Research/Extrapolation-of-indications-in-biosimilars-infliximab
9. Derbyshire M. ECCO 2013 survey highlights lack of confidence in biosimilars. Generics and Biosimilars Initiative Journal (GaBI Journal). 2014;3(3):154. doi:10.5639/gabij.2014.0303.034
10. Kim J, An Hong J, Kudrin A. P137 5 year budget impact analysis of CT-P13 (Infliximab) for the treatment of Crohn's Disease in UK, Italy and France. Poster presentations: Clinical: Diagnosis & outcome (2015). ECCO 2015, Barcelona, Spain; 18-21 February 2015.
Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.
Copyright – Unless otherwise stated all contents of this website are © 2015 Pro Pharma Communications International. All Rights Reserved.
0
Post your comment