摘要
目的 生物类似药评价主要关注质量、有效性和安全性方面的相似性,其中非临床阶段主要是阐述药理毒理特性的相似性。方法 非临床研究遵循比对研究原则和循序递进原则。药学结果的相似性程度决定了后续非临床研究内容,同时非临床阶段的体外试验结果决定后续体内试验研究内容。结果与结论 非临床阶段的相似性评价通过统计学方法进行量化比较,毒性反应的相似性评价主要关注反应类型和程度的差异性。非临床阶段的相似性结果将为后续临床试验设计和评价要求提供参考。
Abstract
OBJECTIVE : To evaluate biosimilar products focus on the similarities in the quality, safety and efficacy between the candidate and reference products. METHODS Comparative non-clinical studies should be conducted and stepwise development should be carried out to demonstrate the similarity in non-clinical study for the candidate and reference products. Usually the necessity and content of in vivo study are dependent on the results of previous comparative studies in vitro.RESULTS AND CONCLUSION Determination of the non-clinical similarity should be based on the statistical analysis of the candidate and reference products. Evaluation for toxicity similarities can focus on toxicity profile in types and extent. The non-clinical similarities will affect the strategy of clinical trial for biosimilars.
关键词
生物类似药 /
非临床研究 /
药理 /
毒理 /
评价
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Key words
biosimilar /
non-clinical study /
pharmacology /
toxicology /
evaluation
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王海学,白玉,谢松梅,高晨燕,罗建辉,尹红章,王庆利*.
关于生物类似药非临床研究与评价的技术思考[J]. 中国药学杂志, 2015, 50(6): 480-482 https://doi.org/10.11669/cpj.2015.06.003
WANG Hai-xue, BAI Yu, XIE Song-mei, GAO Chen-yan, LUO Jian-hui, YIN Hong-zhang, WANG Qing-li*.
Technical Considerations on Non-Clinical Study and Evaluation for Biosimilar Products[J]. Chinese Pharmaceutical Journal, 2015, 50(6): 480-482 https://doi.org/10.11669/cpj.2015.06.003
中图分类号：
S859.79
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参考文献
[1] EMA. Guideline on similar biological medicinal products[S]. 2012.[2] FDA. Draft guidance for Industry-scientific considerations in demonstrating biosimilarity to a reference Product[S].2012.[3] WHO. Guidelines on evaluation of similar biotherapeutic products (SBPs)[S]. 2010.[4] FDA. Guidance on clinical pharmacology data to support a demonstration of biosimilarity to a reference products [S].2014.[5] HPFB. Guidance for sponsors: Informationand submission requirements forsubsequent entry biologics (SEBs)[S].2010.[6] KFDA. Guidelines on the evaluation ofbiosimilar products [S]. 2010.[7] MHLW. Guideline for ensuring quality, safety and efficacy ofbiosimilar products[S]. 2009.[8] DCGI. Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India[S]. 2012.[9] CFDA. Guideline on Development and Evaluation of Biosimilars (2015)[生物类似药研究与评价技术指导原则(试行)] [S]. 2015.[10] LI W, BAI Y.Introduction of biosimilarity products in USA[J]. Chin J New Drugs(中国新药杂志),2014,23(18):2096-2100.
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脚注
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基金
国家科技重大专项“重大新药创制”课题资助项目(2015ZX09501008)
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