86% of physicians responding to a new US survey say they want to be notified before a patient is switched to a different biologic product than the one prescribed, even if there are no known concerns associated with it.
And 85% of physicians responding to the poll said that they want to have the authority to designate a biologic drug as "Dispensed as Written," just as they have it for chemical drugs.Moreover, inappropriate substitution is a major risk if different biologic drugs have the same scientific name, according to the study, which was conducted for the Alliance for Safe Biologic Medicines (ASBM). 64% of surveyed physicians told the researchers they assume that if products have the same name, a patient can be safely switched from one to another during treatment, while more than 76% said they view products with the same scientific name as "structurally identical."
The study findings, which have been presented at the Drug Information Association/US Food and Drug Administration (DIA/FDA) conference on biosimilars in Washington, DC, also reveal that names are the primary means of product identification for physicians. 99% told the survey that they refer to biologic medicines by name for both recording in charts and for reporting adverse events, with fewer than 1% saying that they use national drug code numbers for records or reporting.
Presenting the survey findings, ASBM chairman Dr Richard Dolinar noted that they provide important information for effectively addressing the significant challenges presented for physicians and regulators by making copies of the biologic medicines which have, in the past 30 years, revolutionised the treatment of patients with many diseases.
"Biologics are produced from living cells and copies will be only similar, not identical to the original. This survey clearly indicates that physicians familiar with biologics know minor changes can make a big difference for sick patients," he said.
Dr Dolinar stated that the ASBM has been "very supportive" of the FDA's efforts to create a pathway that ensures biosimilars are safe and effective for patients.
"This survey demonstrates the potential safety consequences of giving difference biologic products the same scientific name. In order to avoid inappropriate substitution, all biologics should be required to have distinctive names," he stressed.