目的 探讨生物类似药研发评价的相关问题。方法 结合《生物类似药研发与评价技术指导原则》(试行)(以下简称《指导原则》)的起草工作,从生物类似药的起源、现行法规中相关内容、对于生物类似药的理解、生物类似药的研发评价思路、研发与评价的问题与难点等方面探讨交流生物类似药及候选药的内在特性与研发风险。结果与结论 建议参照国内颁布的《指导原则》设计适宜的比对性研究,选择适宜的研发路径,评估论证研发工艺、生产规模、研究批次的代表性及合理性,清醒认识比对研究中的技术要求、相似性评判的难度和复杂性,慎重选择和开发生物类似药。

OBJECTIVE To discuss the critical questions on the development and evaluation of biosimilars. METHODS Topics such as the option of developing approach and evaluation method,the original concept and understanding of biosimilars, the challenge and risk of developing biosimilars, the chapter and items related to application of biosimilars in regulation for drug registration, etc., were addressed in combination with the drafting of guidance on biosimilars. RESULTS AND CONCLUSION It was recommended that comparative studies applicable for candidate drugs be designed and appropriate developing approach be selected refering to the guidance on biosimilars. The manufacturing process,scale,and batches used for the comparative studies should be evaluated in terms of representativeness and rationality. The technical requirements as well as the challenge and complexity for the judgement of similarity should also be well understood. The decision on developing biosimilars should be made based on risk analysis and comprehensive understanding of the internal characteristics including critical quality attributes of the reference products and candidate drug.