生物制品的致癌性评估及风险管理策略  

Carcinogenicity assessment and risk management strategies for biological products

作　　者：张素才 宫田田 孙云霞 孙涛 ZHANG Sucai;GONG Tiantian;SUN Yunxia;SUN Tao(Beijing Key Laboratory for Biological Products Safety Evaluation,JOINN Laboratories(Beijing),Beijing 100176,China;Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)

机构地区：[1]北京昭衍新药研究中心股份有限公司,生物制品安全性评价北京市重点实验室,北京100176 [2]国家药品监督管理局药品审评中心,北京100022

出　　处：《药物评价研究》2022年第12期2393-2403,共11页Drug Evaluation Research

基　　金：国家重点研发计划资助项目(2021YFC2302505);建设医药科技成果转移转化公共服务平台项目(2021019611)。

摘　　要：大多数生物制品不会成为完全致癌物,但可以通过其药理学放大作用、免疫调节等成为肿瘤促长剂。在国际人用药品注册技术协调会(ICH)S1A和S6(R1)指导原则中对生物制品的致癌性评估有简单描述,但均缺少明确案例,且未考虑到新型技术药物的出现和监管思路的改变等情况。通过汇总2014—2021年美国食品药品监督管理局(FDA)批准的53项长期用药的生物制品的致癌性信息,并结合文献报道和实际工作经验,从生物制品的致癌性特点、致癌性评估策略、致癌性风险管理等几方面提出一些观点和建议,以期为国内同行、新药申报企业和审评机构提供有益的参考。Most biological products will not become complete carcinogens,but they can be used as tumor promoters through pharmacological amplification,immunomodulatory,etc.The carcinogenicity assessment of biological products is briefly described in the ICH S1A and S6(R1) guidelines,but specific cases are not provided,and the emergence of new technology drugs and changes in regulatory thinking were not taken into account.This paper,summarized the carcinogenicity information of 53 biological products approved by US FDA intended for long-term use from 2014 to 2021,combined with our practical work experience and published literature,tries to provide some views and suggestions in term of carcinogenicity characteristics,carcinogenicity assessment strategy and carcinogenicity risk management of biological products.In order to provide some references for the domestic industries,sponsors and regulatory agencies.

关 键 词：生物制品 致癌性试验 致癌性评估 风险管理 获益-风险框架 

分 类 号：R915[医药卫生—微生物与生化药学] R969.3[医药卫生—药学]