中、美、日、欧等国家/地区生物类似药监管措施的比较研究
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篇名: 中、美、日、欧等国家/地区生物类似药监管措施的比较研究
TITLE: Comparative Study on Regulatory Measures of Biosimilars in China ,the United States ,Japan and Europe
摘要: 目的:为我国生物类似药的药政监管提供参考。方法:查阅我国国家药品监督管理局、美国FDA、欧洲药品管理局以及日本药品医疗器械管理局等药政相关监管部门官方网站公布的权威文件,比较其关于生物类似药的定义、有效性、安全性和临床应用等药政监管措施,并对我国生物类似药监管措施的完善提出建议。结果与结论:各国/地区对生物类似药的定义虽然表述形式不同,但均要求生物类似药应与其对应的参照药具有相同的药品质量、安全性和有效性。美国、欧盟和日本均要求企业提供生物类似药和参照药具有前期药学相似性的研究、药理学和毒理学等非临床研究,以及免疫原性、药动学、药效学等临床研究数据;而我国尚未要求生物类似药和参照药在前期药学研究中具有相似性。各国/地区均对生物类似药的适应证外推持支持态度,其中美国和欧盟要求生产企业提供详尽的数据资料;日本只是提到了生物类似药适应证外推的相关概念,但未提及具体的数据要求,我国对生物类似药适应证外推条件的相关表述也不够清晰,其在我国的应用还面临着巨大的挑战。在药物互换性方面,美国虽允许在州法律许可的条件下以具有可互换性的生物类似药替代参照药,但目前尚无相关生物类似药获得批准;欧洲各国对生物类似药的可互换性规定各不相同;而我国和日本在生物类似药的可互换性方面尚无文件明确提及。建议我国在保障生物类似药的有效性和安全性方面应进一步完善比对原则,适当从严要求;在适应证外推领域,应当提出更详尽的数据要求,并需科学评估外推后可能存在的风险;在生物类似药的可互换性方面,建议尝试推行生物类似药的转换原则,但需经医师、药师和患者共同协商后使用,并实时监测用药安全,同时建立完善的可追溯体系来保障患者的用药安全。
ABSTRACT: OBJECTIVE:To provi de reference for drug admini stration supervision of biosimilars in China. METHODS : Referring to the authoritative documents of the official websites of National Medical Products Administration of China ,FDA of the United States ,European Drug A dministration and Japan ’s D rug and M edical Devices Agency ,and comparing their regulatory measures on the definition ,effectiveness,safety and clinical application of biosimilars,the suggestions were put forward for the improvement of regulatory measures of biosimilars in China. RESULTS & CONCLUSIONS :Although the definitions biosimilars in different countries/regions were different ,they all required that biosimilars should have the same drug quality ,safety and effectiveness as their corresponding reference drugs. The United States ,the European Union and Japan required enterprises to provide studies on the similarity of early pharmacy ,non-clinical studies such as pharmacology and toxicology ,and clinical studies on immunogenicity ,pharmacokinetics and pharmacodynamics of biosimilars and reference drugs. However ,the similarity between biosimilars and reference drugs had not been required in China. All countries/regions supported the extrapolation of indications of biosimilars. Among which the United States and the European Union required manufacturers to provide detailed data ;Japan only mentioned the relevant concepts of indications extrapolation of biosimilars,but did not mention the specific data requirements. The relevant description of the conditions for the extrapolation of biosimilars in China was not clear enough ,and its application in China was still facing great challenges. In terms of drug interchangeability ,although the United States allowed the use of interchangeable biosimilars to replace reference drugs under the conditions permitted by state laws ,no relevant biosimilars had been approved;European countries had different regulations on the interchangeability of biosimilars;but there was no document explicitly mentioned in China and Japan on the interchangeability of biosimilars. It is suggested that the principle of comparison should be further improved and strict requirements should be appropriately enforced in ensuring the effectiveness and safety of biosimilars;in the field of indication extrapolation ,more detailed data requirements should be put forward ,and the possible risks after extrapolation should be evaluated scientifically ;in terms of the interchangeability of biosimilars ,it is suggested to try to implement the principle of conversion of biosimilars ,but it should be used after consultation among doctors ,pharmacists and patients,and drug use safety should be monitored timely. Meanwhile ,a sound traceability system should be established to ensure drug safety of patients.
期刊: 2020年第31卷第24期
作者: 刘聿砚,张相林
AUTHORS: LIU Yuyan ,ZHANG Xianglin
关键字: 生物类似药;有效性;安全性;适应证外推;可互换性;美国;日本;欧洲
KEYWORDS: Biosimilars;Effectiveness;Safety;Indication extrapolation ;Interchangeability;The United States ;Japan;Europe
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