中国生物类似药临床应用循证管理指南(2024)OA北大核心CSTPCD

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.