Clinical Pharmacy Specialist, Kaiser Permanente Colorado, Denver, CO, USA.
Clinical Associate Professor, University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, Aurora, CO, USA.
BioDrugs. 2022 Jan;36(1):1-11. doi: 10.1007/s40259-021-00510-w. Epub 2021 Nov 24.
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.
生物制剂被广泛用于治疗各种疾病，并在多个治疗领域改变了医疗护理方式；然而，它们对医疗保健系统和患者来说都很昂贵。生物类似药的使用（由美国食品药品监督管理局批准为与原创生物制剂“高度相似”）有可能通过为支付方和患者节省大量成本，改变生物制剂领域的医疗保健格局。随着生物类似药的引入，各组织越来越多地评估如何将患者从原创生物制剂转换为生物类似药。虽然已经有一些研究评估了从原创生物制剂转换为生物类似药的患者的结果，但很少有出版物描述医疗保健系统采用并将患者转换为生物类似药的过程。自 2016 年以来，科罗拉多州凯撒永久医疗集团（KPCO）已经进行了几次生物类似药的转换，从第一个进入市场的生物类似药——非格司亭开始，并且能够成功地将 91.8%接受英夫利昔单抗治疗的患者、99.8%接受利妥昔单抗治疗的患者以及 100%接受非格司亭、曲妥珠单抗和贝伐珠单抗原创生物制剂的患者转换为相应的生物类似药。为了支持其他医疗保健系统并为实施生物类似药转换提供框架，本文的目的是描述生物类似药转换模型，并分享 KPCO 的经验教训。
