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. 2015 Mar;21(3):188-95.
doi: 10.18553/jmcp.2015.21.3.188.

Assessment of pharmacists' views on biosimilar naming conventions

Sara Fernandez-Lopez  1 , Denise Kazzaz, Mohamed Bashir, Trent McLaughlin
Affiliations

Assessment of pharmacists' views on biosimilar naming conventions

Sara Fernandez-Lopez et al. J Manag Care Spec Pharm. 2015 Mar.

Abstract

Background: As the date for the introduction of biosimilars in the United States approaches, questions remain regarding the naming, coding, and approval process for these agents that will need to be carefully considered.

Objectives: To (a) ascertain pharmacists' awareness of and comfort level with biosimilars and (b) determine the impact of identical or different nonproprietary names on pharmacists' confidence in substituting interchangeable biologics.

Methods: The Academy of Managed Care Pharmacy, the American Pharmacists Association, and the American Society of Health-System Pharmacists fielded a survey to their membership or a partial segment of their membership. The survey consisted of 2 sections: (1) current processes for reporting biologics being dispensed and (2) familiarity and preferences regarding biosimilars.

Results: A substantial majority (70.1%) of respondents reported regularly using National Drug Code numbers as the identifier for biological products dispensed to patients; however, 10.4% of respondents reported using either the nonproprietary name or the Healthcare Common Procedure Coding System code as the identifier. When presented with 3 scenarios for naming conventions of interchangeable biosimilars and asked to rate their level of confidence (1 = not confident, 5 = very confident) to substitute, 74.6% of pharmacists indicated that they would be confident or very confident in substituting an interchangeable biosimilar with the reference product if both shared the same active ingredient or nonproprietary name of the reference biologic; 25.3% of pharmacists were confident in substituting when the nonproprietary name is not shared with the biologic; and 37.3% of pharmacists expressed confidence in substituting when the biologic and biosimilar product did not share the same nonproprietary name because of a prefix or suffix.

Conclusions: The imminent entry of biosimilars into the U.S. market highlights the need to carefully evaluate current processes of identification, reporting, and recording of the biological products dispensed. The results of this survey indicate that the ultimate decision on the naming convention for biosimilars may influence dispensing pharmacists, with the majority of respondents being most comfortable with biosimilars having the same nonproprietary name as the reference biologic.

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Conflict of interest statement

The study instrument was developed in collaboration with AMCP leadership. The authors report no financial conflicts of interest related to the subject or products mentioned in this article.

Study concept and design were contributed by all the authors. Data collection was performed by Kazzaz, Fernandez-Lopez, and Bashir, and data were analysed by Bashir, Fernandez-Lopez, and Kazzaz. The manuscript was written by Fernandez-Lopez, Kazzaz, and Bashir and revised by McLaughlin, Fernandez-Lopez, Kazzaz, and Bashir.

Figures

FIGURE 1
FIGURE 1
Current Practices for Sharing Dispensing Information
FIGURE 2
FIGURE 2
Methods to Record Which Biologic Product Was Dispensed to Patient (N = 77)
FIGURE 3
FIGURE 3
Confidence of Survey Respondents in Substituting Interchangeable Biosimilars
FIGURE 4
FIGURE 4
Influence of Postdispensing Notification Requirements on Pharmacists’ Likelihood of Substitution
See this image and copyright information in PMC

References

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