140000 cases prove that the safety and effectiveness of centralized generic drugs are equivalent to those of the original research drugs
2023-10-31
Recently, the National Medical Insurance Administration reported the effectiveness and safety research results of 23 selected generic drugs in the second and third batches of national centralized procurement. Since 2018, China has carried out 8 batches of national organized drug procurement, involving 333 types of drugs, with a total of over 216 billion tablets/tablet used nationwide. In order to truly and comprehensively understand the safety and effectiveness of selected generic drugs in centralized procurement, starting from 2021, the National Medical Insurance Administration organized medical institutions such as Xuanwu Hospital of Capital Medical University to conduct real-world research on the clinical efficacy and safety of selected generic drugs in the second and third batches of national mass procurement. The research lasted for two years and has recently produced important research results. The efficacy of the collected generic drugs is consistent with that of the original research drugs. It is understood that this study includes 140000 medical records, including patient diagnoses, prescriptions, examinations, test results, etc. The 23 drugs evaluated this time involve six major fields: anti infection, anti-tumor, metabolic and endocrine, neuropsychiatric, cardiovascular, and digestive systems. The research team leader and director of the Pharmacy Department of Xuanwu Hospital of Capital Medical University, Zhang Lan, gave a detailed introduction to the specific research situation in these six fields and concluded that the clinical efficacy and safety of selected generic drugs in centralized procurement are comparable to those of the original research drugs. Taking anti-tumor drugs as an example, there are 6 drugs included in the study. The effectiveness is evaluated using indicators such as disease-free survival, 5-year disease-free survival, recurrence and metastasis rates, treatment response rates, and tumor marker levels. The safety is evaluated using indicators such as the incidence of adverse drug reactions. The clinical efficacy and safety of five generic drugs, namely Tegio, Azarcytidine, Abiterone, Letrozole, and Anatrazole, are comparable to the original research drug. The treatment response rate of capecitabine generic drugs is higher than the original research drug, reaching 50%, and the original research drug is 30%, with significant statistical differences. In recent years, China's generic pharmaceutical industry has made significant progress in terms of quality, production capacity, and market position. "Chang Feng, Dean of the School of International Pharmaceutical Business at China Pharmaceutical University, stated that since the evaluation of the consistency of generic pharmaceutical quality and efficacy in 2016, China has been in line with international standards in the setting of relevant standards. It has been evaluated that generic pharmaceuticals are consistent with original research drugs in terms of treatment and efficacy, and can be replaced with original research drugs in clinical use. With the deepening of consistency evaluation work, the number of approved drugs has been increasing year by year since 2018. As of the end of 2022, the number of approved drugs reached 3902, involving over 600 varieties. Why do some people still report that generic drugs are not as good as original research drugs? In fact, this is not the first time China has released the results of a comparative study between centrally purchased generic drugs and original research drugs. In 2021, the National Medical Insurance Administration released research results on 14 centralized generic drugs, which showed that these generic drugs were equivalent in effectiveness and safety to the original research drugs. The results of this study two years ago were obtained from over 110000 cases from more than 20 tertiary hospitals in Beijing, including Xuanwu Hospital of Capital Medical University, Peking University First Hospital, Beijing Anzhen Hospital, Peking University Cancer Hospital, etc. The research data includes patient diagnostic information, prescription information, examination and test results, etc. Since the results of two comparative studies have shown that generic drugs and original drugs are equivalent in terms of safety and efficacy. So why do some people still report that the effectiveness of generic drugs is not as good as the original research
Edit：GuoGuo Responsible editor：FangZhiYou
Source：people.cn
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