Researchers Publish Results Of Biosimilar-Switching Studies

In 2017, the Health Department of Brazil’s Federal District ordered that patients currently prescribed Remicade (infliximab) be switched over to the biosimilar, Remsima.  Earlier this month, researchers in Brazil published a one-year follow-up study of patients who underwent the switch.  They reported that, “[l]ike previous European studies, [their] results suggest that the introduction or the switch to CT-P13 appears to be safe. Regarding drug efficacy, the original and the biosimilar showed similar results in most patients.”  They further stated that while “[s]tudies with larger cohorts and longer follow-up are still needed, … preliminary results show that biosimilars may provide an opportunity to reduce health system costs because of their similarity to reference drugs in terms of safety and efficacy.”

On October 4th, researchers at the Bristol Royal Hospital for Children in the UK published the results of a study to assess juvenile patient and parent perceptions of “non-medical biosimilar switching” (i.e., switching for “economic,” as opposed to medical, reasons) prior to a trust-wide mandatory switch from Humira (adalimumab) to a biosimilar product based on guidance from the National Health Service (NHS).  After interviewing nine families, the researchers identified several common concerns including “the medication administration device type; the colour of the medication and administration device; and whether the injections would sting more.”  As to “the relative safety and efficacy of the biosimilar,” however, “most families felt that there would be no significant difference.” Based on patient concerns, the researchers recommended that treatment teams provide patients with “a coherent message from all members of the team,” “written and verbal patient education prior to switching,” and “detailed information on practical aspects of the biosimilar including device types, additives (including preservatives) and delivery logistics” prior to non-medical biosimilar switching.

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