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.

中文翻译：

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肿瘤学中生物仿制药接受和采用的障碍


重要性生物仿制药提供了具有成本效益但临床上无法区分的目标药物复制品。在最初的开发过程中，此类生物药物有望彻底改变医药市场；然而，自2015年美国食品和药物管理局批准第一个生物类似药以来，生物类似药的商业化受到了限制。生物仿制药使用的缺乏在肿瘤学领域可能尤其突出，因为在这个成本特别高的医学领域，生物仿制药的分销将带来数十亿美元的节省。美国，本次审查提供了有关非经济障碍的见解。这篇综述讨论了美国医疗保健专业人员和付款人的心理、态度和教育因素，这些因素可能会减缓生物仿制药的采用。更具体地说，这些因素包括缺乏医疗保健专业教育、对安全性和有效性的担忧以及过于复杂的产品命名系统。结论和相关性生物仿制药的使用途径受到经济因素以及态度和心理因素的阻碍。为了使生物仿制药发挥其降低治疗成本的潜力，从而增加患者的可及性，必须确定并系统地解决经济和非经济因素。