各国生物类似药参照药管理比对研究及完善我国生物类似药参照药管理的建议

参照药是生物类似药研发的标杆,对参照药进行规范管理,有利于保证生物类似药的研发质量。通过对美欧日韩等国家以及WHO对于生物类似药参照药的相关要求进行对比研究,提炼管理要素;结合我国参照药的现状、设计问卷、开展调研和专家研讨;综合对比研究、调研和研讨,提出完善我国生物类似药参照药管理的建议及建议的考量。

Comparative study on the management of reference drug of biosimilar drugs in different countries and recommendation on improvement for China

Reference drugs are the benchmark for the research and development of biosimilar drugs. Standardized management of reference drugs is conducive to ensuring the research and development quality of biosimilar drugs. In this paper, the relevant requirements of countries such as the United States, Europe, Japan and South Korea as well as the WHO on biosimilar-drug reference drugs were compared and studied to extract management elements. Combined with the current situation of reference drugs in China, questionnaire was designed, the research was carried out and the discussion was experted. Based on the comprehensive comparative study, investigation and discussion, the suggestions and considerations for improving the management of biosimilar drugs in China are put forward.