The relatively recent introduction of biosimilars to the US market and the new naming convention for biopharmaceuticals prompted exploration of their impact in clinical practice. Naming guidance for new biological products and biosimilars was published by the US Food and Drug Administration (FDA) in 2017, which proposed the use of a core name followed by a 4-letter suffix devoid of meaning to facilitate pharmacovigilance [1]. In order to find out how this system was viewed by healthcare providers, researchers evaluated use of, knowledge about, perceptions of, and preferences for this naming convention in clinical practice [2]. Previous studies informed the hypothesis that healthcare providers would demonstrate knowledge gaps surrounding biosimilars and opinions regarding 4-letter suffix use would be inconsistent. This study aimed to understand the impact of the recent naming guidance in clinical practice.
A cross-sectional study was performed by distributing a survey to 506 healthcare providers who had previously prescribed or encountered biosimilars in clinical practice. The survey was emailed every two weeks for two months to healthcare providers in two large healthcare systems in Philadelphia: the University of Pennsylvania Health System and the Corporal Michael J Crescenz VA Medical Center. The study aimed to measure knowledge about key information and discern whether certain naming trends were preferred in clinical practice. Differences in responses across pre-hypothesized subgroups were tested for statistical significance using c2 testing and Fisher’s exact testing.
Of the 506 surveys that were sent to prescribers and other clinical staff; 50 were returned from inactive email addresses. Of the remaining 456, 83 (16%) responded. Most were from the University of Pennsylvania, with the highest response rate in the Divisions of Hematology/Oncology and Rheumatology, and the Department of Pharmacy. Although respondents had a general understanding of the regulatory criteria for approval, knowledge was generally poor: only 52% of all respondents correctly identified that a biosimilar differed from a generic drug. When asked about biosimilar naming, 67% reported using the brand name in clinical practice to distinguish between biosimilars and their reference products. In contrast, only a minority of respondents reported regular use of the 4-letter suffix to identify biological products. Notably, most respondents (68% overall) indicated a neutral response when asked if the 4-letter suffix promoted medical errors and most prescribers (76%) indicated that the 4-letter suffix did not affect their decision to use biosimilars. Thus, it appears that the 4-letter suffix has limited utility in clinical care.
The authors therefore concluded that a knowledge gap about biosimilars remains and use of the FDA’s new naming convention in clinical practice is limited. Education and more experience with biosimilars are needed for healthcare providers to familiarize with and increase use of this naming convention in the context of patient care.
Conflict of interest
The authors of the research paper [2] declared that there was no conflict of interest.
Abstracted by Marianna Olave, Rheumatology and Infectious Disease, Medical Research Program, Corporal Michael J Crescenz VA Medical Center, Philadelphia, PA, USA.
Editor’s comment
Readers interested to learn more about naming of biosimilars are invited to visit www.gabi-journal.net to view the following manuscripts published in GaBI Journal:
US FDA proposals for naming of biologicals and labelling of biosimilars
Effect of naming on pharmacists’ perceptions and dispensing of biosimilars
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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA issues draft guidance on naming biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Sep 10]. Available from: www.gabionline.net/Guidelines/FDA-issues-draft-guidance-on-naming-biologicals
2. Olave M, Lavery C, Leonard CE, et al. Knowledge of biosimilars and perceptions of the naming conventions for biosimilar products in clinical practice in the United States. Drug Ther Perspectives. 2021;37:338-46.
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