Nor-Switch: – Safe switch to biosimilar
Nor-Switch study shows no difference between Remicade and biosimilar.
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VIENNA/UEGW: Abstract published tonight shows no significant difference in effect, adverse effects or antibody formation in the tested patients; that either continued treatment with the original substance infliximab (Remicade) or switched from Remicade to a biosimilar drug, infliximab (CT-P13, Remsima).
Tuesday principal investigator Tore K. Kvien is to present the results of the Nor-Switch study at the United European Gastroenterology annual congress week (UEGW).
– The results are not suprising. Now we can underline the answer to the main question whether it is safe or not to switch from Remicade and to a biosimilar such as Remsima or Inflectra (other biosimilar of infliximab), Tore Kvien says to the Norwegian newspaper Dagens Medisin.
Primary endpoint of the study was disease worsening. «Disease worsening occurred in 26,2 percent and 29,6 percent in the INX and CT-P13 arms, respectively (PPS),» the abstract says.
Expects big shift
– When patients ask, the doctors can now show that a switch is safe, based on the data from this study, he points out.
As a result of the last tender between the Norwegian governmental acquisitions company (LIS) and the pharmaceutical companies, Inflectra is now the cheapest biosimilar of infliximab for Norwegian governmental hospitals.
Kvien expects Norwegian doctors to switch all patients on Remicade to Inflectra, the third biosimilar to Remicade.
The doctor also hopes that the data will open up for more patients switching in other countries.
Asks for caution
Kvien asks for caution about drawing conclusions to far:
– By my understanding, we have to be catious with generalizing the results to other biological drugs and their biosimilar. As in all other areas of medicine we need more documentation than this one study, he says.