Obstacles to Biosimilar Acceptance and Uptake in Oncology

Author:

Mroczek Daniel K.12,Hauner Katherina13,Greene George J.1,Kaiser Karen1,Peipert John Devin1,Golf Mary4,Kircher Sheetal4,Shaunfield Sara1,Lylerohr Madison1,Cella David1

Affiliation:

1. Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, Illinois

2. Department of Psychology, Weinberg College of Arts and Sciences, Northwestern University, Chicago, Illinois

3. The Ken and Ruth Davee Department of Neurology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois

4. Division of Hematology and Oncology, Department of Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois

Abstract

ImportanceBiosimilar drugs provide cost-effective yet clinically indistinguishable replications of target drugs. During initial development, this class of biologic medicines was expected to revolutionize pharmaceutical markets; however, following US Food and Drug Administration approval of the first biosimilar drug in 2015, the commercialization of biosimilars has been limited. The lack of biosimilar use may be especially salient in oncology, given that biosimilar distribution in this particularly high-cost area of medicine would bring savings on the order of many billions of dollars.ObservationsWhile researchers have focused on salient economic barriers to biosimilar uptake in the US, the present review provides insight regarding noneconomic barriers. This review discusses psychological, attitudinal, and educational factors among both health care professionals and payers in the US that may play a role in slowing biosimilar uptake. More specifically, these factors include a lack of health care professional education, concerns of safety and efficacy, and overly complex product naming systems.Conclusions and RelevanceThe pathway to biosimilar use has been obstructed by economic elements as well as attitudinal and psychological factors. For biosimilar drugs to achieve their potential in decreasing treatment costs and thus increasing patient access, it will be essential for both economic and noneconomic factors to be identified and systematically addressed.

Publisher

American Medical Association (AMA)

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