首页|抗肿瘤生物类似药临床转换应用及管理的专家共识

抗肿瘤生物类似药临床转换应用及管理的专家共识

扫码查看
原文链接
  • 国家科技期刊平台
  • NETL
  • NSTL
  • 万方数据
为进一步规范生物类似药的临床转换应用,中国抗癌协会肿瘤临床药学专业委员会根据国内外生物类似药转换的法律法规,结合最新的研究数据及我国临床实践,组织相关领域专家讨论并制定共识.在转换的考量因素方面,提高疗效和减少不良反应是临床实践中由生物类似药反向转换到原研药的关键因素,而价格则是原研药主动转换到生物类似药的关键因素.在转换的态度立场方面,原抗肿瘤治疗药物控制良好的情况下应谨慎进行任何形式的转换;若原研药疗效未达预期时,不建议进行生物类似药转换,考虑直接换用其他治疗方案;在抗肿瘤生物类似药转换过程中,应符合药品的适应证且尊重并落实患者的知情权和自主选择权.在转换的管理措施方面,医疗机构应落实抗肿瘤生物类似药转换的药事监管及处方权限管理政策;在生物类似药临床转换后,应加强对患者的短期及长期的疗效及安全性监测.抗肿瘤生物类似药临床转换应用及管理专家共识的制定旨在为抗肿瘤生物类似药转换规则体系的建立及科学监管提供参考.
Expert consensus on clinical application and management of oncology biosimilar switching
In order to further standardize the clinical conversion of biosimilars,the Committee of Oncology Clinical Pharmacy of the Chinese Anti-Cancer Association organized experts in related fields to discuss and formulate this consensus according to the latest research data and clinical practice in China.In terms of considerations for switching,improving efficacy and reducing adverse reactions are key factors in reverse switching from biosimilars to reference biologic drugs,while the price is the key factor in switching from reference biologic drugs to biosimilars.In terms of attitude and stance towards switching,any form of switching should be approached with caution when the original anti-cancer drug is well controlled.If the efficacy of reference biologic drugs does not meet expectations,receiving other treatment options directly would be recommended instead of switching to biosimilars.In the process of switching,it is necessary to comply with the indications of the drug and respect and implement the patient's right to be informed and make autonomous choices.On the management measures for switching,medical institutions should implement pharmaceutical regulatory strategies and prescription authority management.After the clinical switching of biosimilars,the monitoring of short-term and long-term efficacy and safety for patients should be strengthened.Expert consensus on the clinical application and management of oncology biosimilar switching is formulated to provide a reference for the establishment of the rules system and scientific supervision of oncology biosimilar switching.

biosimilaranti-cancer drugswitchingapplication managementconsensus

杜琼、叶璇、朱林蕙、王萌萌、徐蕊、翟青、陈红专

展开 >

复旦大学附属肿瘤医院药剂科,上海 200032

复旦大学上海医学院肿瘤学系,上海 200032

复旦大学附属肿瘤医院闵行院区药剂科,上海 200240

上海中医药大学附属曙光医院未来健康实验室,上海 200025

展开 >

生物类似药 抗肿瘤药 转换 应用管理 专家共识

上海申康医院发展中心临床"五新"创新研发项目上海申康医院发展中心医企融合创新支撑技能培训专项上海市"医苑新星"青年医学人才培养计划-临床药师项目上海市抗癌协会"雏鹰计划"上海市青年药学人才能力提升项目

SHDC2020CR3085BSHDC2022CRS029沪卫人事[2021]99SACA-CY21B04沪药会字[2023]04号

2024

10.19577/j.1007-4406.2024.01.001

中国临床药学杂志
中国药学会

中国临床药学杂志

CSTPCD
影响因子：0.502
ISSN：1007-4406
年,卷(期)：2024.33(1)
  • 39