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首页> 外文期刊>Journal of the advanced practitioner in oncology >Integrating Biosimilars Into Oncology Practice: Implications for the Advanced Practitioner
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Integrating Biosimilars Into Oncology Practice: Implications for the Advanced Practitioner

机译：将生物仿制物体纳入肿瘤学实践：对先进科学人的影响

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摘要

Biosimilar agents are biologic products that have been shown to be "highly similar" to an already approved reference biologic product. Their integration into clinical practice has the potential to significantly decrease costs for patients, health-care systems, and insurance companies. Through legislation, the US Food and Drug Administration (FDA) approved the Biologies Price Competition and Innovation (BCPI) Act in 2009. In 2010, it was signed into law, allowing for an abbreviated pathway for biosimilar approval. This law implemented a framework for development and regulation of biosimilars for manufacturers and provided guidance for the key submission components necessary to achieve final FDA approval. Many factors will influence how biosimilars are integrated into health-care systems and oncology clinics. As biosimilar utilization in the United States expands beyond supportive care, unique challenges will emerge. Patient and staff education will be at the forefront of the successful application of biosimilar agents in oncology, and advanced practitioners will be in a unique position to lead change. The goal of this article is to describe the chemical and clinical nature of biosimilars, review focus areas of interest for biosimilar development in oncology, discuss implementation strategies for biosimilars, and provide techniques for patient education on biosimilars.
机译：生物仿优异剂是已经被证明是已经批准的参考生物产品的“高度相似”的生物制品。他们融入临床实践的融合有可能显着降低患者，医疗保健系统和保险公司的成本。通过立法，美国食品和药品监督管理局（FDA）于2009年批准了“生物学价格竞争和创新（BCPI）法”。2010年，它签署了法律，允许缩写的生物综合批准途径。本法实施了制造商的生物仿制框架的框架，并为实现最终FDA批准所需的主要提交组件提供指导。许多因素会影响生物仿制物如何融入医疗保健系统和肿瘤诊所。由于美国生物仿制性的利用率超出了支持性的关怀，将出现独特的挑战。患者和员工教育将处于成功应用生物仿制药中的肿瘤学中的最前沿，先进的从业者将处于一个独特的地位，以导致变革。本文的目标是描述生物仿制物质的化学和临床性质，审查肿瘤生​​物仿制性发育的重点感兴趣的领域，讨论生物仿制性的实施策略，并为生物纤维单体进行患者教育提供技术。

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