Data from a clinical study in Norway may soon explain the effects of switching stable patients from a biologic medicine, infliximab, to its biosimilar counterpart. But, as the Global Alliance for Patient Access argues in a new white paper, policymakers must accurately interpret what the NOR-SWITCH study will – and will not – demonstrate about the safety of switching.
The paper stems from an international group of physicians and researchers who met in June with NOR-SWITCH investigators to discuss the trial and its potential impact. The group includes leading clinicians from the fields of rheumatology, gastroenterology and dermatology.
NOR-SWITCH, they explain in the paper, is a randomized, double blind study of how patients across six inflammatory diseases respond to being switched from Remicade® to the biosimilar Remsima®. Infliximab is a particularly large and complex biologic medicine.
The study is funded by the Norwegian government but speaks to international interest in how switching patients from biologics to lower-cost biosimilars might reduce health care expenses. At present, little data exist to predict the impact of such switches. Nevertheless, the paper argues, the need for data and the interest in lowering costs should not lead policymakers to exaggerate NOR-SWITCH findings or apply them inappropriately. The paper poses this question: “Will data from this study be used inappropriately to justify policies that mandate:
- Switching of any biosimilar within a class?
- Multiple switches over the course of a treatment period?
- Switching in any disease where biosimilars are available?”
The authors argue that, “…decisions about switching should remain in the hands of the treating physician and his or her patient.”
Biosimilars could offer patients and physicians more treatment options, potentially at lower costs. But for patients to benefit from biosimilars’ “appropriate use,” the paper contends, policymakers must take care in how they interpret – and apply – data on switching.