各国生物类似药上市后监测要求及非可比生物制品对比研究及建议

通过对美国、欧盟、日本、韩国等国家生物类似药上市后监测的管理要求进行比对研究以及对WHO非可比生物制品管理的研究,提炼生物类似药上市后监测和非可比生物制品的管理要素;结合我国现状、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上市后监测及非可比生物制品管理的建议和建议的考量。

Comparative study of the requirements of post-marketing surveillance for biosimilar drugs and non-comparable biological products of different countries and recommendation on improvement for China

In this paper, the management requirements of the post-marketing monitoring of biosimilar drugs in the United States, Europe, Japan, South Korea and other countries were compared, and the management of non-comparable biological products were studied in WHO, so as to extract the management elements of the post-marketing monitoring of biosimilar drugs and non-comparable biological products. Combined with the current situation of China, questionnaire design, research, and expert discussion were carried on. Based on the comprehensive comparative study, investigation and discussion, the suggestions and considerations for improving the post-marketing monitoring and non-comparable biological products management of biosimilar drugs in China are put forward.