Safe for IBD patients to switch to biosimilar infliximab

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Safe for IBD patients to switch to biosimilar infliximab

Biosimilars/Research | Posted 24/02/2017 0 Post your comment

A UK study has shown that inflammatory bowel disease (IBD) patients can be safely switched from originator infliximab, Johnson & Johnson’s and Merck’s Remicade, to biosimilar infliximab using a managed-switching programme [1].

The European Medicines Agency (EMA) approved the first infliximab biosimilar, Inflectra/Remsima (CT‑P13), in 2013. However, according to the authors, to date there is still little information on CT-P13 in IBD patients, and especially in switching patients from the originator biological to biosimilar infliximab.

Dr Fraser Cummings and colleagues from the Southampton General Hospital studied a total of 143 patients with IBD (118 Crohn’s disease, 23 ulcerative colitis and 2 IBD unclassified) who were switched from Remicade to CT-P13.

The results showed a similar incidence of side effects before and after the switch. In addition, no clinically significant differences were observed in mean C-reactive protein (CRP), albumin, haemoglobin levels, or platelet and white cell counts after the switch to CT‑P13, whereas mean IBD-control-8 score improved from 10.4 to 11.2 (p = 0.041). There was also no significant difference in drug persistence between biosimilar and originator infliximab (p = 0.94) and no increase in immunogenicity was found. As a result of switching patients drug acquisition costs for the hospital fell by GBP 40,000‒60,000 per month.

The authors concluded that ‘a managed switching programme from originator infliximab to biosimilar CT-P13 in IBD … delivers significant cost savings … while maintaining similar patient-reported outcomes, biochemical response, drug persistence, and adverse event profile’.

Preliminary results from the NOR-SWITCH study, which studied patients with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn’s disease or chronic plaque psoriasis, have also shown that patients can be safely switched to the biosimilar [2].

European IBD specialists have also recently updated their position statement in support of switching to biosimilars [3].

Switching may not be suitable for patients with immunogenicity

References
1. Razanskaite V, Bettey M, Downey L, Wright J, Callaghan J, Rush M, et al. Biosimilar infliximab in Inflammatory Bowel Disease: outcomes of a managed switching programme. J Crohns Colitis. 2017 Jan 27. pii: jjw216. doi:10.1093/ecco-jcc/jjw216. [Epub ahead of print]
2. GaBI Online - Generics and Biosimilars Initiative. NOR-SWITCH study finds biosimilar infliximab not inferior to originator [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Feb 24]. Available from: www.gabionline.net/Biosimilars/Research/NOR-SWITCH-study-finds-biosimilar-infliximab-not-inferior-to-originator
3. GaBI Online - Generics and Biosimilars Initiative. European IBD specialists support switching to biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Feb 24]. Available from: www.gabionline.net/Biosimilars/General/European-IBD-specialists-support-switching-to-biosimilars

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