中国临床药学杂志2024，Vol.33Issue(1)：1-10,10.DOI:10.19577/j.1007-4406.2024.01.001
抗肿瘤生物类似药临床转换应用及管理的专家共识
Expert consensus on clinical application and management of oncology biosimilar switching
摘要
Abstract
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.关键词
生物类似药/抗肿瘤药/转换/应用管理/专家共识Key words
biosimilar/anti-cancer drug/switching/application management/consensus引用本文复制引用
杜琼,叶璇,朱林蕙,王萌萌,徐蕊,翟青,陈红专..抗肿瘤生物类似药临床转换应用及管理的专家共识[J].中国临床药学杂志,2024,33(1):1-10,10.基金项目
上海申康医院发展中心临床"五新"创新研发项目(编号SHDC2020CR3085B) （编号SHDC2020CR3085B）
上海申康医院发展中心医企融合创新支撑技能培训专项(编号SHDC2022CRS029) （编号SHDC2022CRS029）
上海市"医苑新星"青年医学人才培养资助计划-临床药师项目(编号:沪卫人事[2021]99) （编号:沪卫人事[2021]99）
上海市抗癌协会"雏鹰计划"(编号SACA-CY21B04) （编号SACA-CY21B04）
上海青年药学人才能力提升项目(编号:沪药会字[2023]04号) （编号:沪药会字[2023]04号）
