Three studies presented at the Digestive Disease Week (DDW) 2017 have shown no significant differences in efficacy or safety endpoint. Two of the studies also specifically tested outcomes in patients switching from the originator infliximab product, Remicade, to the biosimilar version.
A study by Young Ho Kim and colleagues of Sungkyunkwan University School of Medicine, Seoul, South Korea, compared Celltrion’s infliximab biosimilar (Remsima, CT-P13) to originator infliximab (Remicade) in patients with active Crohn’s disease (CD). The phase III, randomized, double-blind, controlled trial enrolled 220 patients from 58 study centres across 16 countries. The results, according to the authors, confirmed that ‘CT‑P13 was similar to [originator infliximab] in terms of CDAI-70 [70% reduction in Crohn’s Disease Activity Index score], CDAI-100 and clinical remission up to Week 6 in patients with CD’. The authors also concluded that ‘CT‑P13 was well tolerated with a similar safety profile’ [1].
A second study by Kristin K Joergensen and colleagues of Akershus University Hospital, Lørenskog, Norway, reported results of the two-year-long NOR‑SWITCH study. This phase IV study included 481 patients at 40 sites across Norway who had been on stable infliximab treatment for at least six months. The results of the explorative subgroup analysis of CD and ulcerative colitis (UC), in which approximately half of the patients were switched to Remsima (CT-P13), ‘showed’ according to the authors, ‘similarity between patients treated with [originator infliximab] and CT‑P13 with regards to efficacy, safety and immunogenicity’ [2].
Finally, Anne Samira Strik and colleagues of Academic Medical Center, Amsterdam, The Netherlands, reported results from a switching study in CD patients. The phase IV, prospective, open-label, interventional, non-inferiority trial enrolled 61 CD patients across nine centres. The results, according to the authors, ‘demonstrated that the infliximab serum concentration of the biosimilar was non-inferior to the infliximab concentration of the reference infliximab 16 weeks after switching in patients with CD’. They added that ‘efficacy and tolerability were also similar’ [3].
Celltrion gained European approval for the world’s first monoclonal antibody biosimilar Remsima/Inflectra (infliximab) as part of its collaboration with US-based generics maker Hospira in September 2013 [4]. The approval includes all the indications of the reference biological, Johnson & Johnson and Merck’s Remicade (infliximab), in the European Union. These include treatment of ankylosing spondylitis (AS), CD, psoriatic arthritis, psoriasis, rheumatoid arthritis and UC [5]. Hospira received approval for Inflectra from the US Food and Drug Administration (FDA) in April 2016 [6].
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Remsima shows comparable safety and efficacy in IBD patients
References
1. Kim YH, et al. Phase III randomized, double-blind, controlled trial to compare biosimilar infliximab (CT-P13) with innovator infliximab (INX) in patients with active Crohn's disease: early efficacy and safety results. Gastroenterolgy. 2017;152(5):S1(S65).
2. Joergensen KK, et al. Biosimilar infliximab (CT-P13) is not inferior to originator infliximab: explorative IBD subgroup-analyses in Crohn's disease and ulcerative colitis from the Nor-Switch trial. Gastroenterolgy. 2017;152(5):S1(S65-S66).
3. Strik AS. Unchanged infliximab serum concentrations after switching from the originator infliximab to the biosimilar CT-P13 in patients with quiescent Crohn's disease: a prospective study. Gastroenterolgy. 2017;152(5):S1(S65-66).
4. GaBI Online - Generics and Biosimilars Initiative. EC approves first monoclonal antibody biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jun 9]. Available from: www.gabionline.net/Biosimilars/News/EC-approves-first-monoclonal-antibody-biosimilar
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jun 9]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
6. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jun 9]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
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