The Norwegian government pledged 20m NOK ($2.5m) in 2013 to compare J&J’s reference monoclonal antibody Remicade (infliximab/INX) with the approved biosimilar Remsima (CT-P13), made by Celltrion, in order to help facilitate switching.
Results of the 52-week randomised, double-blind, non-inferiority, phase IV ‘NOR-SWITCH’ study which began in October 2014 were presented today during the United European Gastroenterology (UEG) Week in Vienna, Austria.
“The NOR-SWITCH trial demonstrated that switch from INX to CT-P13 was not inferior to continued treatment with INX,” the study concluded.
Drugmaker Pfizer - which markets its infliximab biosimilar Inflectra, also made by Celltrion, in the EU and is soon to do the same in the US – told this publication:
“The study met its primary endpoint demonstrating that switching from Remicade to Inflectra was not inferior to continued treatment with Remicade – i.e., there was no statistically significant difference in disease worsening between Remicade and Inflectra.”
However, the Global Alliance for Patient Access (GAfPA) – a US non-profit physician group funded by major biopharma and biosimilar makers - expressed its concerns that the results may be taken “as a ‘carte blanche’ to switch stable patients from a biologic medicine to a biosimilar for non-medical and purely financial reasons.”
As such, the group has urged caution against switching of any biosimilar within a class, multiple switches over the course of a treatment period, and switching in any disease where biosimilars are available.
“We don’t believe the study results should be used by policymakers as a basis to permit switching of all patients in every instance, and in no instances without physician participation and patient’s informed consent,” the group told Biopharma-Reporter.
“Biosimilars are inherently different from their referenced product and in addition they are approved according to different standards. Accordingly, there needs to be extra caution exercised when extrapolating between conditions.”
Through extrapolation of clinical data, Remsima/Inflectra has been approved for use for all six of Remicade’s indications in Europe and the US: Crohn’s disease (CD), ulcerative colitis (UC), spondyloarthritis (SpA), rheumatoid arthritis (RA), psoriatic arthritis (PsA) and chronic plaque psoriasis (Ps).
However in Israel, for example, extrapolation to IBD indications (CD and UC) has not been granted.
Correction: Originally the article stated extrapolation to IBD indications had not been granted in Canada. While this was the case when Inflectra was approved in 2014, Health Canada approved the extra indications in June this year.