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Switching from Biologic to Biosimilar Products: Insight from an Integrated Health Care System
BioDrugs ( IF 5.4 ) Pub Date : 2021-11-24 , DOI: 10.1007/s40259-021-00510-w
Bharati Bhardwaja 1, 2 , Shilpa Klocke 1, 2 , Ekim Ekinci 1 , Adam Jackson 1 , Kari L. Olson 1, 2 , Scott Kono 3
Affiliation  

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:

从生物制品转向生物仿制药:来自综合医疗保健系统的洞察

生物制剂适用于多种疾病的治疗,并改变了多个治疗领域的护理;然而,它们对医疗保健系统和患者来说都是昂贵的。被美国食品和药物管理局批准为与原研生物“高度相似”的生物仿制药的使用有可能通过为支付方和患者节省大量成本来改变生物领域的医疗保健格局。随着生物仿制药的推出,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,但很少有出版物描述医疗保健系统采用和将患者转向生物仿制药的过程。自 2016 年以来,Kaiser Permanente Colorado (KPCO) 从第一个推向市场的生物仿制药 filgrastim 开始,进行了多次生物仿制药转换,并且能够成功转换 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、曲妥珠单抗和贝伐珠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 的经验教训。8% 接受利妥昔单抗,100% 接受非格司亭、曲妥珠单抗和贝伐珠单抗原研生物制剂的各自生物仿制药。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 的经验教训。8% 接受利妥昔单抗,100% 接受非格司亭、曲妥珠单抗和贝伐珠单抗原研生物制剂的各自生物仿制药。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 的经验教训。

更新日期:2021-11-25
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