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.”
More from Biopharma Reporter