FDA证明生物类似药与参照药可互换的考虑要点

发布时间：2018-04-04 06:41

本文选题：生物类似药　切入点：可互换性　出处：《中国新药杂志》2017年15期

【摘要】：生物类似药是指在质量、安全性和有效性方面与已获准注册的参照药具有相似性的治疗用生物制品。要做到生物类似药与参照药具有可互换性,FDA要求必须在已进行生物类似药研究的基础上,进一步证明患者使用候选产品后能得到与参照药相同的临床结果,即在多次替换或交替用药后的安全性和疗效降低的风险不大于仅用参照药时。FDA于2017年1月发布了生物类似药可互换性指南草案——"证明与参照药品可互换性的考虑",要求对生物类似药的可互换性提供相关数据,重点是临床试验的设计和数据解析。草案对临床试验的研究终点、临床试验方案的设计、研究人群、试验条件、给药途径、适应证外推等多方面提出了建议。
[Abstract]:Biological analogues are therapeutic biologics that are similar in quality, safety, and effectiveness to approved reference drugs.In order for bioanalogues and reference drugs to be interchangeable, the FDA requires that, on the basis of research on bioanalogous drugs, it is necessary to further prove that patients can obtain the same clinical results as reference drugs after using candidate products.That is, the risk of safety and efficacy reduction after multiple or alternate use is not greater than that with reference drugs alone. The FDA issued a draft guideline on the interchangeability of bioanalogous drugs in January 2017.Consider "requesting relevant data on the interchangeability of bioanalogous drugs,Emphasis is placed on the design of clinical trials and data analysis.The draft provides suggestions on the end point of clinical trial, the design of clinical trial scheme, the study population, the test conditions, the route of administration, the indication extrapolation and so on.
【作者单位】：国家食品药品监督管理总局药品审评中心;第二军医大学卫生毒理学教研室;苏州华测生物技术有限公司;
【基金】：国家“重大新药创制”科技重大专项资助项目(2014ZX09J14106) 国家自然科学基金资助项目(81473291,81402651,81402654)
【分类号】：R95

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