各国生物类似药立法发展现状和批准产品的研究进展.PDF

现代药物与临床 Drugs Clinic 第 34 卷 第 4 期 2019 年 4 月 ·883 · 各国生物类似药立法发展现状和批准产品的研究进展 1 1 2 3* 李光慧 ，林 涛 ，王海辉 ，杨建红 1. 安进生物技术咨询（上海）有限公司，上海 200020 2. 辉瑞投资有限公司，北京 100000 3. 沈阳药科大学 亦弘商学院，北京 100027 摘 要：通过对美国、欧盟、日本、韩国及我国生物类似药的立法发展及法规进行梳理，了解我国生物类似药法规方面存在 的主要差异。通过对美国、欧盟、日本、韩国及我国生物类似药的批准及在研情况进行梳理，摸清国内外生物类似药的上市 及研发现状，为我国生物类似药法规体系研究奠定基础。主要综述了各国生物类似药立法发展现状和批准产品的研究进展。 关键词：生物类似药；立法发展；法规政策；批准及在研数据 中图分类号：R951 文献标志码：A 文章编号：1674 - 5515(2019)04 - 0883 - 06 DOI: 10.7501/j.issn.1674-5515.2019.04.002 Research progress on current situation of bio-similar drug legislation and approved products in various countries 1 1 2 3 LI Guang-hui , LIN Tao , WANG Hai-hui , YANG Jian-hong 1. Amgen Biotechnology Consulting (Shanghai) Co., Ltd., Shanghai 200020, China 2. Pfizer Investment Co. Ltd., Beijing 100000, China 3. School of Yeehong Business, Shenyang Pharmaceutical University, Beijing 100027, China Abstract: Through reviewing the legislative development and regulations of bio-similar drugs in the United States, European Union, Japan, Korea, and China, the main differences in bio-similar drugs laws and regulations in China are understood. Through reviewing the approval and research status of bio-similar drugs in the United States, the European Union, Japan, Korea, and China, the status quo of domestic and foreign bio-similar drugs’ marketing and research are found out, and lay a foundation for the research of bio-similar drugs regulatory system in China. The current situation of bio-similar drug legislation and approved products in various countries are reviewed in this paper. Key words: bio-similar drug; legislative development; legal policy; approval and data in progress 在生物制品领域，随着日益加重的社会福利负 研究与分析，为我国生物类似药法规体系研究奠定 担和患者用药的可及性等问题的出现，发达国家建