Evidence-based guideline for the management of clinical application of biosimilars in China （2024 edition）

SONG Zaiwei; HU Yang; YU Lingling; ZHU Jun; ZHANG Lingli; ZHANG Yu; MIAO Liyan; ZHAI Suodi; ZHAO Rongsheng

doi:10.6039/j.issn.1001-0408.2024.16.01

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Evidence-based guideline for the management of clinical application of biosimilars in China （2024 edition）

更新时间：2024-08-23

- Evidence-based guideline for the management of clinical application of biosimilars in China （2024 edition）
- ZHONGGUO YAOFANG Vol. 35, Issue 16, Pages: 1933-1945(2024)
- 作者机构：
  
  1.北京大学第三医院药学部，北京;100191
  2.北京大学医学部药物评价中心，北京　100191
  3.北京大学治疗药物监测和临床毒理学中心，北京　100191
  4.北京大学肿瘤医院暨北京市肿瘤防治研究所淋巴肿瘤内科，北京　100142
  5.中国临床肿瘤学会淋巴瘤专家委员会
  6.四川大学华西第二医院药学部/循证药学中心，成都　610044
  7.中国药学会循证药学专业委员会
  8.海峡两岸医药卫生交流协会医院药学专业委员会
  9.华中科技大学同济医学院附属协和医院药学部，武汉　430022
  10.中国药学会医院药学专业委员会
  11.苏州大学附属第一医院药学部，江苏苏州　215006
  12.中国药理学会治疗药物监测研究专业委员会
  13.中国医院协会医院药学联合体
- 作者简介：
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2024.16.01
  CLC： R95
- Published：30 August 2024，
  
  Received：06 May 2024，
  
  Revised：27 June 2024，
- 稿件说明：
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宋再伟,胡杨,余玲玲等.中国生物类似药临床应用循证管理指南（2024） ^Δ[J].中国药房,2024,35(16):1933-1945.

SONG Zaiwei,HU Yang,YU Lingling,et al.Evidence-based guideline for the management of clinical application of biosimilars in China （2024 edition）[J].ZHONGGUO YAOFANG,2024,35(16):1933-1945.
宋再伟,胡杨,余玲玲等.中国生物类似药临床应用循证管理指南（2024） ^Δ[J].中国药房,2024,35(16):1933-1945. DOI： 10.6039/j.issn.1001-0408.2024.16.01.

SONG Zaiwei,HU Yang,YU Lingling,et al.Evidence-based guideline for the management of clinical application of biosimilars in China （2024 edition）[J].ZHONGGUO YAOFANG,2024,35(16):1933-1945. DOI： 10.6039/j.issn.1001-0408.2024.16.01.

摘要

目的

为生物类似药临床应用与管理提供规范化指导，促进其广泛、合理地用于临床治疗。

方法

遵循《WHO指南制订手册（第2版）》等指南研究方法学规范进行《中国生物类似药临床应用循证管理指南（2024）》的设计、规划、制订流程和全文报告，并充分考虑当前最佳循证医学证据、多学科专家经验和患者意愿及价值观，采用推荐意见分级的评估、制订与评价（GRADE）方法评价证据质量并确定推荐意见强度。结果与

结论

《中国生物类似药临床应用循证管理指南（2024）》共形成10条推荐意见，其中强推荐7条、弱推荐3条。推荐意见涵盖生物类似药临床应用管理全流程，医疗机构及相关卫生监管部门可参考本指南科学管理生物类似药未获批适应证的外推应用，医务人员可参考本指南进行用药前评估、患者教育、用药前预处理、用药方案调整，多学科治疗团队可参考本指南提供涵盖治疗前、中、后全流程的药物警戒与患者管理。

Abstract

OBJECTIVE

To provide standardized guidance for the clinical application and management of biosimilars， and promote their widespread and rational use in clinical treatment.

METHODS

The design， planning， and drafting process as well as the full report of

Evidence-based Guideline for the Management of Clinical Application of Biosimilars in China

（

2024 Edition

）

followed the

WHO Handbook for Guideline Development

（

2nd edition

）， which fully considered the best current evidence from evidence-based medicine， multidisciplinary expert experience， and patient preferences and values. Grading of Recommendations Assessment， Development， and Evaluation （GRADE） approach was adopted to evaluate the quality of evidence and determine the strength of recommendations.

RESULTS

CONCLUSIONS

Evidence-based Guideline for the Management of Clinical Application of Biosimilars in China

（

2024 Edition

）

presented 10 recommendations including 7 strong recommendations and 3 weak recommendations. The recommendations covered the entire process of clinical application and management of biosimilars. Medical institutions and relevant health regulatory departments can refer to this guideline for the scientific management of the extrapolation of unapproved indications of biosimilars. Healthcare providers can refer to this guideline for pre-treatment assessments， patient education， pre-treatment regimen before administration， and dosage regimen adjustments. Multidisciplinary medical teams can refer to this guideline to provide pharmacovigilance and patient management throughout the treatment process.

关键词

生物类似药临床应用指南循证医学患者意愿

Keywords

clinical applicationguidelineevidence-based medicinepatient willingness

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ZHANG Lingli

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Department of Pharmacy， Evidence-based Pharmacy Center， West China Second University Hospital， Sichuan University

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