生物类似药质量相似性评价和技术要求

Quality Similarity Evaluation and Technical Requirement of Biosimilar Products

目的探讨生物类似药质量相似性评价和技术要求。方法调研国内外生物类似药质量相似性研究和评价相关技术指南,结合生物类似药的研发特点和审评实践,形成生物类似药质量相似性评价和技术要求的基本考虑。结果与结论质量相似性研究是生物类似药整体相似性评价和适应症外推的基础,其药学开发应围绕参照药的目标产品质量概况进行研究和设计。本研究详细阐述生物类似药药学研究的技术要求,包括参照药和候选药的选择、关键质量属性的认知和评估、药学研究和评价要素等,并侧重对生物类似药质量相似性研究和评价的科学考量展开详细讨论,包括质量属性风险评估、质量相似性评价方法和标准、质量相似性研究结果评估以及支持生物类似药整体相似性和适应症外推的物质基础评价等,为生物类似药质量相似性评价提供细化和规范的指导建议,供工业界、研发者及监管机构参考。

OBJECTIVE To explore biosimilarity evaluation and technical requirement of biosimilar products.METHODS Investigations were conducted on the technical guidelines on quality similarity assessment and evaluation for biosimilar products both domestic and aborad.The general considerations for quality similarity evaluation and technical requirements were formed based on the development characteristics and techinical review practices of biosimilar products.RESULTS AND CONCLUSION Biosimilar products are therapeutic biologics which is similar to the marketed reference products in the perspective of quality,safety and efficacy.Quality biosimilarity study is the basis of biosimilar products overall similarity evaluation and indication extrapolation.The pharmaceutical development of biosimilar products should focus on the research and design of the quality target product profile(QTPP)of reference products.In this article,it is expected to interpret in detail the technical requirements of pharmaceutical research and evaluation,including the choice of reference and candidate products,the assessment of critical quality attributes,the key elements of chemistry,manufacture and control(CMC)development and evaluation etc.Besides,the article is mainly focused on quality consideration on biosimilarity study and evaluation,including risk assessment of quality attributes,quality biosimilarity assessment approach and criteria,the result analysis of biosimilarity,the material basis to support the overall biosimilarity and indication extrapolation,in the purpose of providing detail and common advice to quality biosimilarity assessment to industry,researchers and regulatory agencies.