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刊物信息

期刊名称:药物分析杂志
主管单位:中国科学技术协会
主办单位:中国药学会
承办:中国食品药品检定研究院
主编:金少鸿
地址:北京天坛西里2号
邮政编码:100050
电话:010-67012819,67058427
电子邮箱:ywfx@nicpbp.org.cn
国际标准刊号:ISSN 0254-1793
国内统一刊号:CN 11-2224/R
邮发代号:2-237
 

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中国生物类似药研发与评价技术指导原则评析

A note on the Chinese draft guidance on biosimilar products

分类号:
出版年·卷·期(页码):2015,35 (5):0-0
DOI: 10.16155/j.0254-1793.2017.01.01
-----摘要:-------------------------------------------------------------------------------------------

中国国家食品药品监督管理总局(CFDA)组织药品审评中心(CDE)等技术部门,起草《生物类似药研发与评价技术指导原则(征求意见稿)》(以下简称"征求意见稿"),并于2014年10月29日公开向社会征求意见。尽管本征求意见稿与美国食品药品监督管理局(FDA)于2012年2月9日颁布的指南草案非常相近,但是我们认为本征求意见稿个别条款甚至比FDA的草案更加严谨。例如,CFDA的征求意见稿要求在候选药与参照药之间证明相似性时需考虑批内和批间的相似性。CFDA的征求意见稿甫一出台即吸引了制药企业、生物科技产业、监管机构以及学术界的广泛关注。本文拟对参照药的异质性,非劣效性试验在评估生物等效性中的应用,比例标化的平均生物等效性准则(SABE)的潜在应用,批内和批间变异性在生物等效性评估中的考虑等几项关键问题做一讨论。

-----英文摘要:---------------------------------------------------------------------------------------

On October 29, 2014, the Center for Drug Evaluation(CDE)of the China Food and Drug Administration(CFDA)circulated a draft guidance on the evaluation of biosimilar products for public input and comments.Although the draft guidance is very similar to the draft guidance published by the United States(US)Food and Drug Administration(FDA)on February 9, 2012, it is considered a bit more stringent.For example, the CDE/CFDA guidance requests that the intra-batch and inter-batch similarity be taken into consideration when demonstrating biosimilarity between a biosimilar product and an innovative(reference)product.The CDE/CFDA draft guidance has attracted much attention from the pharmaceutical and biotechnology industry, regulatory agencies, and academia worldwide since it was published.In this note, we intend to comment on several critical issues such as the heterogeneity of reference product, the assessment of similarity by non-inferiority trials, the potential use of a scaled average bioequivalence criterion(SABE), and taking intra-and inter-batch variabilities into consideration for assessing similarity.Recommendations will be provided whenever possible.

-----参考文献:---------------------------------------------------------------------------------------
[1] CDE/CFDA.Draft Guideline on Development and Evaluation of Biosimilars(Chinese Version)[S].2014
[2] CHOW SC.Biosimilars:Design and Analysis of Follow-on Biologics[M].New York:Chapman and Hall/CRC Press, Taylor & Francis, 2013
[3] KANG SH, CHOW SC.Statistical assessment of biosimilarity based on relative distance between follow-on biologics[J].Stat Med, 2013, 32(3):382
[4] CHOW SC, LIU JP. Design and Analysis of Bioavailability and Bioequivalence Studies[M].3rd ed.New York:Chapman Hall/CRC Press, Taylor& Francis, 2008
[5] FDA.Guidance on Bioavailability and Bioequivalence Studies for Orally Administrated Drug Products - General Considerations[S].2003
[6] HAIDAR SH, DAVIT B, CHEN ML, et al.Bioequivalence approaches for highly variable drugs and drug products[J].Pharm Res, 2008, 25(1):237
[7] TOTHFALUSI L, ENDRENYI L, GARCIA-ARETA A.Evaluation of bioequivalence for highly-variable drugs with scaled average bioequivalence[J].Clin Pharmacokinet, 2009, 48(11):725
[8] FDA.Scientific Considerations in Demonstrating Biosimilarity to a Reference Product[S].2012
[9] CHOW SC.On assessment of analytical similarity in biosimilar studies[J].Drug Des, 2014, 3(3):119.doi:10.4172/2169-0138.1000e124

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