Naming and labelling of biologicals – the perspective of hospital and retail pharmacists

Abstract

Introduction: To date, the Food and Drug Administration (FDA) has offered only draft guidance on the naming of biosimilar medicines. The Alliance for Safe Biologic Medicines (ASBM) has asked pharmacists for their views on the labelling and naming of biosimilar medicines. Study objectives: To determine the opinions of pharmacists about labelling and naming of biosimilars. Methods: A total of 3,525 pharmacists in the US were invited to complete a survey on the naming and labelling of biologicals. Responses were received from 849 pharmacists, of which 401 completed the survey. Of the pharmacists who completed the survey, 60% worked in hospitals or the healthcare system, 40% worked in retail. Pharmacists were asked for their feedback on a recent FDA non-proprietary biologicals naming proposal. They were also 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. Results: Of the 401 pharmacists who completed the survey, 68% responded that FDA should require a distinct non-proprietary scientific name for every biological product - originator or biosimilar - approved by them. A total of 77% of respondents thought that a manufacturer-specific suffix should be included in the name of each biological product. Respondents considered the following as very important for label inclusion: clinical data to support whether or not the product was a biosimilar and whether or not the biosimilar and originator are interchangeable. Noting that the drug was a biosimilar was considered the most important; whether or not it was interchangeable was slightly less important. Conclusion: A total of 401 pharmacists (11.4% of all those invited) completed the survey. The respondents comprised of 241 hospital pharmacists (60%) and 160 retail pharmacists (40%). Of these the majority of total respondents (68%) think that originator biological and biosimilars should have distinguishable non-proprietary scientific names and 77% think the name should include a unique, distinguishing suffix specific to the manufacturer for future product approval.