Remsima and Inflectra not inferior to Remicade, NOR-SWITCH study finds

A two year-long Phase IV study has shown Celltrion’s infliximab biosimilar is not inferior to its originator Remicade, but a physician group still urges caution when switching.

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.”

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