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.PDF

现代药物与临床 Drugs Clinic 第 34 卷 第 4 期 2019 年 4 月 ·907 · 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 1 2 3 4 5* 王 曦 ，靳 征 ，朱永红 ，余 美 ，张克坚 1. 旭化成医药科技（北京）有限公司，北京 100020 2. 沈阳三生制药有限责任公司，辽宁 沈阳 110027 3. 罗氏研发（中国）有限公司，上海 200335 4. 沈阳药科大学 亦弘商学院，北京 100027 5. 广东华南新药创制中心，广东 广州 510670 摘 要：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。 关键词：生物类似药；上市后监测；非可比生物制品；比对研究；问卷调研；建议 中图分类号：R951 文献标志码：A 文章编号：1674 - 5515(2019)04 - 0907 - 04 DOI: 10.7501/j.issn.1674-5515.2019.04.007 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 1 2 3 4 5 WANG Xi , JIN Zheng , ZHU Yong-hong , YU Mei , ZHANG Ke-jian 1. AsahiKASEI, Beijing 100020, China 2. 3SBIOINC, Shenyang, Shenyang 110027, China 3. Roche, Shanghai 200335, China 4. School of Yeehong Business, Shenyang Pharmaceutical University, Beijing 100027, China 5. The South China Center for Innovative Pharmaceuticals, Guangzhou 510670, China Abstract: 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