Methodological quality assessment of comparative studies on generic drugs and original drugs from 2020 to 2025_Chinese Journal of Evidence-Based Medicine

Authors：

YANG Mengting ^1,2,3,4,5 , HE Siyi ^1,2,3,4,6 , HU Dan ^1,2,3,4 , DIAO Sha ^1,2,3,4,5,7 , YU Qin ^2,3,4,8 , ZHU Yizhun ⁹ ,  ZENG Linan ^1,2,3,4,10 ,  ZHANG Lingli ^1,2,3,4,7,10

1. Department of Pharmacy/Evidence-Based Pharmacy Center, West China Second University Hospital, Sichuan University, Chengdu 610041, P. R. China;
2. Children's Medicine Key Laboratory of Sichuan Province Chengdu 610041, P. R. China;
3. NMPA Key Laboratory for Technical Research on Drug Products in Vitro and in Vivo Correlation, Chengdu 610041, P. R. China;
4. Key Laboratory of Birth Defects and Related Diseases of Women and Children, Sichuan University, Ministry of Education, Chengdu 610041, P. R. China;
5. West China School of Medicine, Sichuan University, Chengdu 610041, P. R. China;
6. West China School of Pharmacy, Sichuan University, Chengdu 610041, P. R. China;
7. Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu 610041, P. R. China;
8. National Drug Clinical Trial Institution of West China Second Hospital, Sichuan University, Chengdu 610041, P. R. China;
9. School of Pharmacy, Macau University of Science and Technology, Macau 999078, P. R. China;
10. West China Biomedical Big Data Center, West China Hospital, Sichuan University, Chengdu 610041, P. R. China;

Corresponding?author：

ZENG Linan, Email: LinanZeng@scu.edu.cn; ZHANG Lingli, Email: zhanglingli@scu.edu.cn

Keywords：

Generic drugs; Brand-name drugs; Comparative study; Methodological quality; Systematic review

DOI：

10.7507/1672-2531.202511073

Video：

Export PDF Favorites Scan Get Citation

Abstract Full text Figures/Tables Video References Cited by

Objective To systematically review comparative studies of generic versus brand-name drugs published from 2020 to 2025, evaluate their methodological quality, and synthesize high-quality evidence to inform rational clinical use and policy development. Methods We searched PubMed, Embase, Cochrane Library, CNKI, VIP, WanFang Data, and CBM databases for studies published between 2020 and 2025. Two reviewers independently screened articles and extracted data. We used appropriate tools to evaluate study quality based on design. We conducted descriptive analyses of study characteristics and synthesized results from high-quality studies. Results We included 125 studies from countries such as China, Russia, and the United States. Most studies used single-center cohort designs (44.0%) with medium (100 to 500 cases, 39.2%) or large samples (500 to 5 000 cases, 30.4%). These studies covered over 90 drugs, mainly in cardiovascular, oncology, and anti-infective fields. We rated 55 studies (44.0%) as high quality. Common issues included limited follow-up, missing sample size estimation, and weak confounding control. Among high-quality studies, about 80% found no major differences in efficacy or safety between generic and brand-name drugs. Some also showed cost advantages for generics. Conclusion Research comparing generic and brand-name drugs has grown over the past five years. High-quality studies support clinical equivalence and substitution. Future studies should follow more rigorous methods to provide stronger evidence for clinical practice and policymaking.

Citation： YANG Mengting, HE Siyi, HU Dan, DIAO Sha, YU Qin, ZHU Yizhun, ZENG Linan, ZHANG Lingli. Methodological quality assessment of comparative studies on generic drugs and original drugs from 2020 to 2025. Chinese Journal of Evidence-Based Medicine, 2026, 26(9): 1053-1058. doi: 10.7507/1672-2531.202511073 Copy

1.	陳新, 吳倩, 溫寶書. 化學仿制藥質量和療效一致性評價工作進展及展望[J]. 中國新藥雜志, 2020, 29(19): 2185-2189.
2.	許金棟, 楊穎, 單玲玲. 仿制藥纈沙坦氨氯地平治療高血壓的臨床效果[J]. 臨床合理用藥, 2024, 17(20): 32-34.
3.	陳思煌, 謝菡, 魏璟璇, 等. 藥品集中采購政策背景下仿制藥與原研藥有效性和安全性對比的系統綜述[J]. 中南藥學, 2023, 21(10): 2787-2792.
4.	邊妍, 潘蕓蕓, 陳吉生. 硫酸氫氯吡格雷片仿制藥對比原研藥治療冠心病的療效、安全性與經濟性的系統評價[J]. 中國藥房, 2018, 29(21): 2980-2984.
5.	付文華, 侯超. 國產與進口纈沙坦治療原發性高血壓病的系統評價[J]. 天津藥學, 2018, 30(3): 45-48.
6.	周虹, 林志強, 蔡文杰, 等. 國產與進口紫杉醇抗腫瘤療效和安全性的系統評價[J]. 中國醫院用藥評價與分析, 2018, 18(2): 211-214, 220.
7.	陳朝鑫, 鄭斌, 鄭歡芮, 等. 通過仿制藥質量和療效一致性評價仿制藥經濟學研究的系統評價[J]. 中國藥物經濟學, 2020, 15(7): 10-19.
8.	國家衛生健康委辦公廳. 關于規范開展藥品臨床綜合評價工作的通知[Z]. 2021.
9.	國家食品藥品監督管理局. 關于仿制藥質量和療效一致性評價工作有關事項的公告: 2017年第100號[Z]. 2017.
10.	World Health Organization. Anatomical Therapeutic Chemical (ATC) classification[Z].
11.	Higgins JPT, Sterne JAC, Savovi? J, et al. Revised Cochrane risk of bias tool for randomized trials (RoB 2.0)[Z]. 2016.
12.	劉津池, 劉暢, 華成舸. 隨機對照試驗偏倚風險評價工具RoB2(2019修訂版)解讀[J]. 中國循證醫學雜志, 2021, 21(6): 737-744.
13.	Sterne JA, Hernan MA, Reeves BC, et al. ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions[J]. BMJ, 2016, 355: i4949.
14.	王浩, 唐曉宇, 王和平, 等. ROBINS-I: 評估非隨機干預性研究偏倚風險的新工具[J]. 中國循證心血管醫學雜志, 2018, 10(7): 789-793.
15.	Wells GA, Shea B, O’Connell D, et al. The Newcastle-Ottawa scale (NOS) for assessing the quality of nonrandomized studies in meta-analyses[Z]. 2025.
16.	曾憲濤, 劉慧, 陳曦, 等. Meta分析系列之四: 觀察性研究的質量評價工具[J]. 中國循證心血管醫學雜志, 2012, 4(4): 297-299.
17.	Rostom A, Dube C, Cranney A, et al. Celiac disease. Rockville (MD): Agency for Healthcare Research and Quality[Z], 2004.
18.	Ofman JJ, Sullivan SD, Neumann PJ, et al. Examining the value and quality of health economic analyses: implications of utilizing the QHES[J]. J Manag Care Pharm, 2003, 9(1): 53-61.
19.	肖軍, 孫謹芳, 王琦琦, 等. 衛生經濟學評價報告指南及應用現狀[J]. 中華預防醫學雜志, 2017, 51(3): 276-280.
20.	Hong QN, Pluye P, Fàbregues S, et al. Improving the content validity of the mixed methods appraisal tool: a modified e-Delphi study[J]. J Clin Epidemiol, 2019, 111: 49-59.
21.	Hong QN, Gonzalez-Reyes A, Pluye P. Improving the usefulness of a tool for appraising the quality of qualitative, quantitative and mixed methods studies, the mixed methods appraisal tool (MMAT)[J]. J Eval Clin Pract, 2018, 24(3): 459-467.
22.	廖星, 胡瑞學, 李博, 等. 混合方法研究評價工具的介紹: MMAT[J]. 中國全科醫學, 2021, 24(31): 4015-4020.
23.	Shea BJ, Reeves BC, Wells G, et al. AMSTAR 2: a critical appraisal tool for systematic reviews that include randomised or non-randomised studies of healthcare interventions, or both[J]. BMJ, 2017, 358: j4008.
24.	張郁, 王傳輝. 醫藥專利制品剝削性高價行為之反壟斷規制研究[J]. 經濟法論叢, 2020, (2): 3-33.

1. 陳新, 吳倩, 溫寶書. 化學仿制藥質量和療效一致性評價工作進展及展望[J]. 中國新藥雜志, 2020, 29(19): 2185-2189.
2. 許金棟, 楊穎, 單玲玲. 仿制藥纈沙坦氨氯地平治療高血壓的臨床效果[J]. 臨床合理用藥, 2024, 17(20): 32-34.
3. 陳思煌, 謝菡, 魏璟璇, 等. 藥品集中采購政策背景下仿制藥與原研藥有效性和安全性對比的系統綜述[J]. 中南藥學, 2023, 21(10): 2787-2792.
4. 邊妍, 潘蕓蕓, 陳吉生. 硫酸氫氯吡格雷片仿制藥對比原研藥治療冠心病的療效、安全性與經濟性的系統評價[J]. 中國藥房, 2018, 29(21): 2980-2984.
5. 付文華, 侯超. 國產與進口纈沙坦治療原發性高血壓病的系統評價[J]. 天津藥學, 2018, 30(3): 45-48.
6. 周虹, 林志強, 蔡文杰, 等. 國產與進口紫杉醇抗腫瘤療效和安全性的系統評價[J]. 中國醫院用藥評價與分析, 2018, 18(2): 211-214, 220.
7. 陳朝鑫, 鄭斌, 鄭歡芮, 等. 通過仿制藥質量和療效一致性評價仿制藥經濟學研究的系統評價[J]. 中國藥物經濟學, 2020, 15(7): 10-19.
8. 國家衛生健康委辦公廳. 關于規范開展藥品臨床綜合評價工作的通知[Z]. 2021.
9. 國家食品藥品監督管理局. 關于仿制藥質量和療效一致性評價工作有關事項的公告: 2017年第100號[Z]. 2017.
10. World Health Organization. Anatomical Therapeutic Chemical (ATC) classification[Z].
11. Higgins JPT, Sterne JAC, Savovi? J, et al. Revised Cochrane risk of bias tool for randomized trials (RoB 2.0)[Z]. 2016.
12. 劉津池, 劉暢, 華成舸. 隨機對照試驗偏倚風險評價工具RoB2(2019修訂版)解讀[J]. 中國循證醫學雜志, 2021, 21(6): 737-744.
13. Sterne JA, Hernan MA, Reeves BC, et al. ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions[J]. BMJ, 2016, 355: i4949.
14. 王浩, 唐曉宇, 王和平, 等. ROBINS-I: 評估非隨機干預性研究偏倚風險的新工具[J]. 中國循證心血管醫學雜志, 2018, 10(7): 789-793.
15. Wells GA, Shea B, O’Connell D, et al. The Newcastle-Ottawa scale (NOS) for assessing the quality of nonrandomized studies in meta-analyses[Z]. 2025.
16. 曾憲濤, 劉慧, 陳曦, 等. Meta分析系列之四: 觀察性研究的質量評價工具[J]. 中國循證心血管醫學雜志, 2012, 4(4): 297-299.
17. Rostom A, Dube C, Cranney A, et al. Celiac disease. Rockville (MD): Agency for Healthcare Research and Quality[Z], 2004.
18. Ofman JJ, Sullivan SD, Neumann PJ, et al. Examining the value and quality of health economic analyses: implications of utilizing the QHES[J]. J Manag Care Pharm, 2003, 9(1): 53-61.
19. 肖軍, 孫謹芳, 王琦琦, 等. 衛生經濟學評價報告指南及應用現狀[J]. 中華預防醫學雜志, 2017, 51(3): 276-280.
20. Hong QN, Pluye P, Fàbregues S, et al. Improving the content validity of the mixed methods appraisal tool: a modified e-Delphi study[J]. J Clin Epidemiol, 2019, 111: 49-59.
21. Hong QN, Gonzalez-Reyes A, Pluye P. Improving the usefulness of a tool for appraising the quality of qualitative, quantitative and mixed methods studies, the mixed methods appraisal tool (MMAT)[J]. J Eval Clin Pract, 2018, 24(3): 459-467.
22. 廖星, 胡瑞學, 李博, 等. 混合方法研究評價工具的介紹: MMAT[J]. 中國全科醫學, 2021, 24(31): 4015-4020.
23. Shea BJ, Reeves BC, Wells G, et al. AMSTAR 2: a critical appraisal tool for systematic reviews that include randomised or non-randomised studies of healthcare interventions, or both[J]. BMJ, 2017, 358: j4008.
24. 張郁, 王傳輝. 醫藥專利制品剝削性高價行為之反壟斷規制研究[J]. 經濟法論叢, 2020, (2): 3-33.

Chinese Journal of Evidence-Based Medicine

Methodological quality assessment of comparative studies on generic drugs and original drugs from 2020 to 2025

Abstract Full text Figures/Tables Video References Cited by

Previous Article

Next Article

Format

Content