大多數(shù)生物制品不會成為完全致癌物，但可以通過其藥理學(xué)放大作用、免疫調(diào)節(jié)等成為腫瘤促長劑。在國際人用藥品注冊技術(shù)協(xié)調(diào)會（ICH）S1A和S6（R1）指導(dǎo)原則中對生物制品的致癌性評估有簡單描述，但均缺少明確案例，且未考慮到新型技術(shù)藥物的出現(xiàn)和監(jiān)管思路的改變等情況。通過匯總2014—2021年美國食品藥品監(jiān)督管理局（FDA）批準(zhǔn)的53項(xiàng)長期用藥的生物制品的致癌性信息，并結(jié)合文獻(xiàn)報(bào)道和實(shí)際工作經(jīng)驗(yàn)，從生物制品的致癌性特點(diǎn)、致癌性評估策略、致癌性風(fēng)險(xiǎn)管理等幾方面提出一些觀點(diǎn)和建議，以期為國內(nèi)同行、新藥申報(bào)企業(yè)和審評機(jī)構(gòu)提供有益的參考。

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.

R915;R969.3

國家重點(diǎn)研發(fā)計(jì)劃資助項(xiàng)目(2021YFC2302505);建設(shè)醫(yī)藥科技成果轉(zhuǎn)移轉(zhuǎn)化公共服務(wù)平臺項(xiàng)目(2021019611)