生物仿制药在肿瘤学领域被接受和采用的障碍:综述。

IF 28.4 1区 医学 Q1 Biochemistry, Genetics and Molecular Biology
Daniel K Mroczek, Katherina Hauner, George J Greene, Karen Kaiser, John Devin Peipert, Mary Golf, Sheetal Kircher, Sara Shaunfield, Madison Lylerohr, David Cella
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引用次数: 0

摘要

重要性:生物仿制药提供具有成本效益但在临床上无差别的目标药物复制品。在开发初期,这一类生物药品有望彻底改变医药市场;然而,在美国食品药品管理局于 2015 年批准首个生物仿制药后,生物仿制药的商业化一直受到限制。生物仿制药在肿瘤领域的使用不足可能尤为突出,因为生物仿制药在这一成本特别高的医药领域的销售将带来数十亿美元的节约:虽然研究人员关注的重点是美国生物仿制药应用的突出经济障碍,但本综述提供了有关非经济障碍的见解。本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,这些因素可能在减缓生物类似药的吸收方面发挥作用。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:经济因素以及态度和心理因素阻碍了生物类似药的使用。要实现生物类似药在降低治疗成本方面的潜力,从而提高患者的可及性,就必须识别并系统地解决经济和非经济因素。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Obstacles to Biosimilar Acceptance and Uptake in Oncology: A Review.

Importance: Biosimilar 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.

Observations: While 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 relevance: The 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.

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来源期刊
Jama Oncology
Jama Oncology Medicine-Oncology
CiteScore
37.50
自引率
1.80%
发文量
423
期刊介绍: At JAMA Oncology, our primary goal is to contribute to the advancement of oncology research and enhance patient care. As a leading journal in the field, we strive to publish influential original research, opinions, and reviews that push the boundaries of oncology science. Our mission is to serve as the definitive resource for scientists, clinicians, and trainees in oncology globally. Through our innovative and timely scientific and educational content, we aim to provide a comprehensive understanding of cancer pathogenesis and the latest treatment advancements to our readers. We are dedicated to effectively disseminating the findings of significant clinical research, major scientific breakthroughs, actionable discoveries, and state-of-the-art treatment pathways to the oncology community. Our ultimate objective is to facilitate the translation of new knowledge into tangible clinical benefits for individuals living with and surviving cancer.
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