报告题目：Assessing Biosimilarity and Interchangeability: Issues and Recent Development

报告时间：2017年6月8日（周四）10:00-11:30

报告地点：南校区.第四教学楼101教室

报 告 人： Shein-Chung Chow（美国杜克大学医学院）

主办单位：药物分析学科

           医疗器械学院

           研究生处（学科建设办公室）

           辽宁省研究生现代药物领域创新与交流中心

报告人简介：

Shein-Chung Chow，美国杜克大学医学院生物信息学教授、杜克大学临床研究所教授、美联邦政府技术顾问、美国食品药品监督管理局成员。学术兼职：American Statistical Association、International Statistical Institute、International Chinese Statistical Association、Drug Information Association、Society for Clinical Trials、AAPS。编写各种教材、著作30多部，发表论文300多篇，国家级以上会议作大会报告100多次。熟练应用SAS, SPSS, BMDP, Minitab, PASS, IMS Routines等软件进行生物信息学领域的统计分析研究。

报告内容简介：

        Biological drugs are much more complicated than chemically synthesized, small-molecule drugs. For instance, their size is much larger and structure is more complicated. In addition, they can be sensitive to environmental conditions such as light, temperature or pressure. Moreover, they may expose patients to immunogenic reactions. Consequently, the assessment of biosimilarity and interchangeability calls for greater circumspection than the evaluation of bioequivalence. The FDA recommends the use of stepwise approach for obtaining totality-of-the-evidence for demonstration of biosimilarity and interchangeability. The stepwise approach involves analytical similarity assessment, animal studies for toxicity, pharmacokinetic and pharmacodynamics (PK/PD) studies for pharmacological activities, clinical studies including immunogenicity for safety, tolerability, and efficacy. The present communication discusses some current issues and recent development related to the assessment of biosimilarity and interchangeability of biosimilar products. The current issues include (1) biosimilar versus biobetter, (2) how many biosimilar studies are required?, (3)  multiple reference products, (4) criteria for highly variable drug products, (5) development of biosimilarity index, (6) analytical similarity assessment for critical quality attributes, (7) drug interchangeability in terms of switching and alternation, (8) study designs that are useful for the assessment of biosimilarity and drug interchangeability, and (9) the issue of (post-approval) non-medical switching, (10) extrapolation of data (both analytical and clinical) across different indications. These issues and corresponding recent development will be discussed.