Evidence-based guideline for the management of clinical application of biosimilars in China （2024 edition）
- VernacularTitle:中国生物类似药临床应用循证管理指南（2024）
- Author:
Zaiwei SONG
1
,
2
,
3
;
Yang HU
1
,
2
,
3
;
Lingling YU
1
,
2
,
3
;
Jun ZHU
4
,
5
;
Lingli ZHANG
6
,
7
,
8
;
Yu ZHANG
9
,
10
;
Liyan MIAO
11
,
12
;
Suodi ZHAI
1
,
2
,
3
;
Rongsheng ZHAO
1
,
2
,
3
Author Information
1. Department of Pharmacy，Peking University Third Hospital，Beijing 100191，China
2. Institute for Drug Evaluation，Peking University Health Science Center，Beijing 100191，China
3. Therapeutic Drug Monitoring and Clinical Toxicology Center，Peking University，Beijing 100191，China
4. Department of Lymphoma，Peking University Cancer Hospital & Beijing Institute for Cancer Research，Beijing 100142，China
5. Expert Committee on Lymphoma，Chinese Society of Clinical Oncology
6. Department of Pharmacy/Evidence-based Pharmacy Center，West China Second University Hospital，Sichuan University，Chengdu 610044，China
7. Evidence-based Pharmacy Professional Committee，Chinese Pharmaceutical Association
8. Hospital Pharmacy Professional Committee，Cross-Straits Medicine Exchange Association
9. Department of Pharmacy，Union Hospital，Tongji Medical College，Huazhong University of Science and Technology，Wuhan 430022，China
10. Hospital Pharmacy Professional Committee，Chinese Pharmaceutical Association
11. Department of Pharmacy，the First Δ 基金项目 国家自然科学基金项目 （No.72304007，No.720740- 05）
12. BHTPP- Affiliated Hospital of Soochow University，Jiangsu 2022079） Suzhou 215006，China
- Publication Type:Journal Article
- Keywords:
biosimilars;
clinical application;
guideline;
evidence-based medicine;
patient willingness
- From:
China Pharmacy
2024;35(16):1933-1945
- CountryChina
- Language:Chinese
-
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.
