Progress of real-world research of the generic and innovator drugs under the national centralized drug procurement policy
10.12173/j.issn.1005-0698.202502083
- VernacularTitle:集采背景下仿制药与原研药临床应用的真实世界研究进展
- Author:
Bin ZHANG
1
;
Minna LIU
;
Xiaolin LI
;
Jinhu LI
;
Tianlong LIU
Author Information
1. 中国人民解放军联勤保障部队第九四〇医院感染科(兰州 730050)
- Publication Type:Journal Article
- Keywords:
National centralized drug procurement;
Real world study;
Clinical evaluation;
Generic drugs;
Innovator drugs;
Effectiveness;
Safety
- From:
Chinese Journal of Pharmacoepidemiology
2025;34(6):690-701
- CountryChina
- Language:Chinese
-
Abstract:
With the normalization and institutionalization of national centralized drug procurement(NCDP)policy,a large number of generic drugs have been included in the clinical frontline,benefiting hundreds of millions of patients.At the same time,real-world studies(RWS)on generics and innovator drugs have been carried out successively,providing evidence-based support for the promotion and optimization of NCDP policy.Thispaper systematically reviewed the RWS of generic drugs in the past fiveyears of the NCDP policy,discussed and summarized the evidence of clinical efficacy,safety and cost-effectiveness of major generic drugs such as anti-infective drugs,cardiovascular drugs,neuropsychotics,hypoglycemic drugs,and anti-tumor drugs,and analyzed the current RWS status of generic drugs.Overall,the clinical effectiveness and safety of domestic generic drugs are basically the same as that of the innovator drugs,and there is no statistically significant difference,while generic drugs are more cost-effective.Current research still reveals shortcomings in in data quality and integrity,standardization and rigor of research methods,study coverage and population diversity,pharmacoeconomic evaluation and long-term safety monitoring,which point out the direction for later research in this field.Throughsystematic integration and analysis of the RWS of generic drugs,this review is expected to improve public awareness and recognition of NCDP policy,and provide an important reference for promoting the in-depth implementation of NCDP policy.
