Biologics are indicated for the treatment of a wide range of conditions and have transformed care in several therapeutic areas; however, they are expensive for both health care systems and patients. The use of biosimilars, which are approved by the US Food and Drug Administration as being "highly similar" to the originator biologic, has the potential to change the health care landscape in the biologic space through considerable cost savings for both payors and patients. With the introduction of biosimilars, organizations are increasingly evaluating how to switch patients from originator biologics to biosimilars. While published studies have evaluated the outcomes of patients switched from originator biologics to biosimilars, there are few publications describing the process health care systems have used to adopt and switch patients to biosimilars. Since 2016, Kaiser Permanente Colorado (KPCO) has undertaken several biosimilar switches starting with the first biosimilar introduced to the market, filgrastim, and has been able to successfully switch 91.8% of patients receiving infliximab, 99.8% receiving rituximab, and 100% receiving filgrastim, trastuzumab, and bevacizumab originator biologics to their respective biosimilars. In an effort to support other health care systems and provide a framework for implementing biosimilar switches, the purpose of this paper is to describe the biosimilar switch model and share learnings from the KPCO experience.

中文翻译：

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从生物制品转向生物仿制品：来自综合医疗保健系统的见解。

生物制剂适用于治疗多种疾病，并已在多个治疗领域改变了护理方式；然而，它们对医疗保健系统和患者来说都是昂贵的。生物仿制药被美国食品和药物管理局批准为与原研生物“高度相似”，它有可能通过为付款人和患者节省大量成本来改变生物领域的医疗保健格局。随着生物仿制药的引入，组织越来越多地评估如何将患者从原研生物制剂转换为生物仿制药。虽然已发表的研究评估了患者从原研生物制剂转向生物仿制药的结果，很少有出版物描述了医疗保健系统用于采用和将患者转换为生物仿制药的过程。自 2016 年以来，Kaiser Permanente Colorado (KPCO) 已经进行了数次生物仿制药转换，从第一个引入市场的生物仿制药非格司亭开始，已经能够成功转换 91.8% 接受英夫利昔单抗、99.8% 接受利妥昔单抗和 100% 接受非格司亭的患者、曲妥珠单抗和贝伐单抗原研生物制剂到各自的生物仿制药。为了支持其他医疗保健系统并提供实施生物仿制药转换的框架，本文的目的是描述生物仿制药转换模型并分享 KPCO 经验中的经验教训。Kaiser Permanente Colorado (KPCO) 已经进行了几次生物仿制药转换，从第一个引入市场的生物仿制药非格司亭开始，已经能够成功转换 91.8% 的接受英夫利昔单抗的患者，99.8% 的接受利妥昔单抗的患者，以及 100% 的接受非格司亭、曲妥珠单抗的患者，和贝伐单抗原创生物制剂到各自的生物仿制药。为了支持其他医疗保健系统并提供实施生物仿制药转换的框架，本文的目的是描述生物仿制药转换模型并分享 KPCO 经验中的经验教训。Kaiser Permanente Colorado (KPCO) 已经进行了几次生物仿制药转换，从第一个引入市场的生物仿制药非格司亭开始，已经能够成功转换 91.8% 的接受英夫利昔单抗的患者，99.8% 的接受利妥昔单抗的患者，以及 100% 的接受非格司亭、曲妥珠单抗的患者，和贝伐单抗原创生物制剂到各自的生物仿制药。为了支持其他医疗保健系统并提供实施生物仿制药转换的框架，本文的目的是描述生物仿制药转换模型并分享 KPCO 经验中的经验教训。和贝伐单抗原创生物制剂到各自的生物仿制药。为了支持其他医疗保健系统并提供实施生物仿制药转换的框架，本文的目的是描述生物仿制药转换模型并分享 KPCO 经验中的经验教训。和贝伐单抗原创生物制剂到各自的生物仿制药。为了支持其他医疗保健系统并提供实施生物仿制药转换的框架，本文的目的是描述生物仿制药转换模型并分享 KPCO 经验中的经验教训。