A study of 54 people with inflammatory bowel disease (IBD) in Finland showed that switching to biosimilar infliximab has no significant impact on health-related quality of life or disease activity, while reducing costs by two thirds [1].
The monoclonal antibody infliximab is used to treat a number of inflammatory diseases, including IBD. IBD includes Crohn’s disease and ulcerative colitis, rates of which disease are increasing in Europe [2].
As a biological drug, infliximab is an expensive treatment for IBD, motivating the development of biosimilars. The first infliximab biosimilar to be sold in Europe was Remsima (CT-P13), manufactured by the South Korean firm Celltrion. It was approved in Europe in 2013. The company has since launched a subcutaneous version of Remsima in Europe [3].
Studies showing the equivalent efficacy of the biosimilar in ankylosing spondylitis and rheumatoid arthritis were extrapolated to IBD, which raised concern among some. However, the Milassin review has concluded that switching from originator infliximab to CT-P13 in IBD is safe and acceptable, but more evidence is needed regarding switching back to originator (reverse switching), multiple switching between drugs, and switching between biosimilars (cross-switching) [4].
Huoponen et al. [1] assessed the impact of switching from originator to biosimilar infliximab (CT-P13) on a group of IBD patients in Finland. The study evaluated the impact of switching on health-related quality of life, disease activity and healthcare costs.
The study was conducted at a single centre in Finland and measured health-related quality of life and disease activity in 54 IBD patients switched from originator infliximab (Remicade, Janssen Biotech/Schering-Plough) to biosimilar infliximab (Remsima, Celltrion). Quality of life and disease activity was assessed at the time of switching, as well as 3 and 12 months after switching.
Health-related quality of life was assessed using the generic 15D questionnaire, which assesses 15 aspects of quality of life including mobility, sleep, discomfort and symptoms. Disease-specific health-related quality of life information was collected using the IBD questionnaire, a standardized assessment method in IBD.
Disease activity was measured using the Crohn’s disease Activity Index, Partial Mayo Score (a non-invasive assessment of IBD) and fecal calprotectin levels, a measure of inflammation.
During the one-year follow-up period, the study found no significant changes in health-related quality of life or disease activity following switching to biosimilar infliximab. Although there was a statistically significant improvement in IBD questionnaire scores in patients with Crohn’s disease 3 months after switching, there was no longer a significant difference at 12 months post-switching.
In terms of costs, biosimilar infliximab was just 35% of the cost of the originator product, representing a significant saving on drug costs. The total costs of health care however (secondary health care, excluding the costs of infliximab) were similar after switching. Example of secondary healthcare costs include laboratory tests, ambulatory and outpatient visits and radiology tests.
On the basis of their findings, the authors suggest that biosimilar infliximab is comparable to the originator product, but at one third of the costs. However, they do note limitations to their study, including the relatively small number of patients enrolled in the study and the lack of a control group continuing on originator infliximab.
Conflict of interest
Some of the authors received research support and consulting fees from pharmaceutical companies. For full details of the authors’ conflict of interest, see the research paper [1].
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References
1. Huoponen S, Eberl A, Räsänen P, Roine R. Medicine (Baltimore). Health-related quality of life and costs of switching originator infliximab to biosimilar one in treatment of inflammatory bowel disease. 2020;99(2):e18723.
2. Burisch J, Martinato TJM, Lakatos PL, ECCO–EpiCom. The burden of inflammatory bowel disease in Europe. J Crohns Colitis. 2013;7(4):322-37.
3. GaBI Online - Generics and Biosimilars Initiative. Celltrion launches infliximab biosimilar Remsima SC in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 31]. Available from: www.gabionline.net/Biosimilars/News/Celltrion-launches-infliximab-biosimilar-Remsima-SC-in-Europe
4. GaBI Online - Generics and Biosimilars Initiative. Is switching to biosimilar infliximab safe? [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 31]. Available from: www.gabionline.net/Biosimilars/Research/Is-switching-to-biosimilar-infliximab-safe
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