生物类似药药学研究的挑战

Challenges of Pharmaceutical Evaluation of Biosimilars

目的在《生物类似药研发与评价技术指导原则》新出台的背景下,就生物类似药药学研究存在的一些挑战进行分析探讨。方法从原研药的研究、细胞表达系统和工艺、分析方法和质量控制参数、免疫学特性以及制剂配方和包材等方面提出生物类似药药学开发中,面临的一些挑战和难题。结果与结论通过对上述问题的分析,提出生物类似药药学研究的建议。同时,建议研发企业充分考虑开发生物类似药面临的风险和挑战,研发出与原研药质量一致的产品,满足国内公众用药需求的同时,实现与国际要求的接轨。

OBJECTIVE To propose some challenges of the pharmaceutical studies on biosimilars. METHODS Some key points should be considered,including the investigation of original biologics,cell expression system and manufacture process,analytical methods and quality attributes,immunological properties,and formulation and primary packaging materials,when a biosimilar was developed. RESULTS AND CONCLUSION Some suggestions we proposed on the pharmaceutical evaluation of biosimilars. Meanwhile,it is suggested that sponsors should be aware of the challenges and difficulties of developing biosimilars and develop biosimilars with equivalent quality to the original products,which not only meets the need of the public for the medicines,but also adapts to the international requirements.