| 关于生物仿制药临床评价的探讨 |
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| 引用本文： | 杨焕.关于生物仿制药临床评价的探讨[J].中国临床药理学与治疗学,2009,14(1):5-9. |
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| 作者姓名： | 杨焕 |
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| 作者单位： | 国家食品药品监督管理局药品审评中心审评五部,北京,100038 |
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| 摘 要： | 我国已上市和正在申报的生物制品绝大多数都是生物仿制药（biosimilar products），关于此类药物的临床研究如何评价，目前国内尚未制定相关的指导原则和技术要求，本文期望通过借鉴国外最新相关指导原则的内容和观点，结合国情为我所用。
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| 关 键 词： | 生物仿制药 临床评价 |
Discussions on clinical evaluation for biosimilar products |
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| YANG Huan.Discussions on clinical evaluation for biosimilar products[J].Chinese Journal of Clinical Pharmacology and Therapeutics,2009,14(1):5-9. |
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| Authors: | YANG Huan |
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| Institution: | YANG Huan (Center for Drug Evaluation , State Food and Drug Administration , Beijing 100038, China) |
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| Abstract: | In China, the majority of biological products on the market and under new drug application are biosimilar ones, and there are no guidelines and technical requirements on clinical assessment for biosimilar products available now. We expect to obtain some useful information in this field in referring to the updated international guidelines. |
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| Keywords: | biosimilar products clinical evaluation |
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