Results of a two-year phase IV study have shown that Celltrion Healthcare (Celltrion)’s infliximab biosimilar (Remsima, CT-P13) is not inferior to the originator biological Remicade.
Results of the NOR-SWITCH study were presented on 18 October 2016 at the United European Gastroenterology (UEG) Week in Vienna, Austria.
The NOR-SWITCH study was designed to generate safety and efficacy data to reassure physicians that the biosimilar version is just as good and that could facilitate greater switching of patients who are already receiving the originator product, Johnson & Johnson’s and Merck’s rheumatoid arthritis blockbuster Remicade (infliximab) . It was sponsored by the Norwegian Government and included nearly 500 patients at 40 sites across Norway who had been on stable infliximab treatment for at least six months.
Approximately half of the patients were switched to Remsima (CT-P13) and the findings showed that efficacy and safety were comparable between this group and those who remained on the originator. The findings also indicated that the time to study drug discontinuation was almost identical between the two groups. Further data presented at the UEG Week on remission rates in Crohn’s disease and ulcerative colitis showed that the remission rate with biosimilar infliximab (CT-P13) was comparable to the originator.
However, some physician groups are still urging caution when switching. The European Federation of Pharmaceutical Industries and Associations (EFPIA) and European Biopharmaceutical Enterprises (EBE) welcomed the results of the NOR-SWITCH study as a ‘step in the right direction’ towards obtaining robust data that can ‘enhance physician and patient confidence in using biosimilars’. However, they also pointed out that the study does not address multiple switches and switching between different biosimilar infliximab products.
In addition, the Global Alliance for Patient Access (GAfPA) – a US non-profit physician group funded by major biopharma and biosimilars makers – expressed its concerns that the results may be taken ‘as a ‘carte blanche’ to switch stable patients from a biologic[al] medicine to a biosimilar for non-medical and purely financial reasons’.
Sandoz could provide some data on multiple switching. Malte Peters, Head of Global Clinical Biopharmaceutical Development at Sandoz pointed out that ‘in the NOR-SWITCH study patients switched once, from Remicade to biosimilar infliximab. In our EGALITY study, patients switched between biosimilar etanercept and the reference product three times. The EGALITY data show that multiple treatment switches have no impact on safety and efficacy’. Sandoz used the EGALITY data to support its submission for approval of its etanercept biosimilar (GP2015) .
Mr Peters added that ‘the EGALITY study provides robust clinical study data that physicians are asking for so they can be confident in switching their patients from originator etanercept to biosimilar etanercept’.
Further data on switching biosimilar infliximab is expected in April 2017, when a study being carried out in The Netherlands is expected to be completed .
Norwegian study may be slowing adoption of biosimilar infliximab
1. GaBI Online - Generics and Biosimilars Initiative. Norwegian study hopes to increase biosimilars uptake in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Oct 21]. Available from: www.gabionline.net/Biosimilars/General/Norwegian-study-hopes-to-increase-biosimilars-uptake-in-Europe
2. GaBI Online - Generics and Biosimilars Initiative. EMA accepts application for etanercept biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Oct 21]. Available from: www.gabionline.net/Biosimilars/News/EMA-accepts-application-for-etanercept-biosimilar
3. GaBI Online - Generics and Biosimilars Initiative. Another infliximab switching trial started [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Oct 21]. Available from: www.gabionline.net/Biosimilars/News/Another-infliximab-switching-trial-started
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Source: Celltrion, EFPIA, GAfPA, Medicines for Europe, UEG