Naming and labelling of biologicals – a survey of US physicians’ perspectives

Introduction: The US Food and Drug Association (FDA) released its requirements for the non-proprietary naming of biological products in January 2017. Before the FDA's release, the Alliance for Safe Biologic Medicines (ASBM) asked physicians for their views on the labelling and naming of biosimilar medicines.Study objectives: To determine the opinions of physicians who prescribe biologicals about labelling and naming of biologicals/biosimilars.Methods: 400 prescribers of biologicals in the US were asked what information they would like to see included in a biological product label in order to choose between multiple biosimilars and their reference products. In a separate survey, 400 prescribers were asked how biosimilars should be named. In the labelling survey, prescribers were asked what information should be included in a label, such as what clinical data should be present; whether the product was a biosimilar; and whether or not it was interchangeable. In the naming survey, prescribers were asked for their opinion on product naming in general and on what were then FDA proposals (now FDA requirements) for biosimilar naming.Results: All items queried in the labelling survey were considered very important for label inclusion. The fact that a drug was a biosimilar was considered the most important; whether it was interchangeable was marginally less important. In the naming survey, 66% of respondents thought that FDA should require a distinct non-proprietary scientific name for every FDA-approved biological product--whether originator or biosimilar. 60% thought that a manufacturer-specific suffix should be added to the name.Conclusion: The physicians surveyed generally agree on the issue of the labelling of biosimilars. Two thirds of respondents to the naming survey agreed that FDA should require a distinct non-proprietary scientific name for every biological product they approve--whether originator or biosimilar. However, 53% did not support FDA's proposal to add a random suffix to the name, and would prefer a suffix that indicated the manufacturer.Keywords: ASBM, biosimilar, interchangeability, labelling, legislation, naming