目的 生物类似药临床相似性研究的目的是评价候选药在临床安全有效性方面与参照药的相似性,这需要设计并开展科学合理的临床试验来证明。本文的目的是提出生物类似药临床试验设计中的关键问题以及解决思路。方法 通过对国内外生物类似药研发的现状和多国监管机构的技术指导原则的综合分析,形成生物类似药临床研究的总体考虑要点。结果与结论 根据原研产品特征以及药学、非临床比对研究结果,用简化的、少而精的临床试验,来证明候选药与参照药的等效性,以此来桥接原研产品(参照药)已经被认可的有效性和安全性。临床研究设计中,准确的适应证、敏感的受试人群、恰当的评价指标等,都将为生物类似药的最终相似性评价提供有价值的数据和有力证据。

OBJECTIVE : To evaluate the similarity of biosimilars in clinical safety and efficacy between the candidate and reference products. This evaluation requires designing and conducting scientific and reasonable clinical trials. This report aims at raising key issues in clinical study for biosimilars and giving solutions to the respective problems.METHODS The principle of clinical study of biosimilars was established based on the current development of biosimilar products and the guidances on biosimilars evaluation of multiple countries.RESULTS AND CONCLUSION A good clinical study for biosimilars should be designed based on the feature of the original product and the results of the chemistry,manufacturing, and controls(CMC) and non-clinical studies. With some simplified but high-quality studies to prove the equivalence of the candidates and reference product, the safety and efficacy of the original product could bridge the biosimilar product. In the clinical trial design, accurate indications, sensitive subjects and appropriate endpoint are essential to provide valuable data and solid evidence for the final evaluation of similarity.