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放大作用、免疫調節(jié)等成為腫瘤促長劑。在國際人用藥品注冊技術協(xié)調會（ICH）S1A和S6（R1）指導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）批準的53項長期用藥的生物制品的致癌性信息，并結合文獻報道和實際工作經驗，從生物制品的致癌性特點、致癌性評估策略、致癌性風險管理等幾方面提出一些觀點和建議，以期為國內同行、新藥申報企業(yè)和審評機構提供有益的參考。

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

國家重點研發(fā)計劃資助項目(2021YFC2302505);建設醫(yī)藥科技成果轉移轉化公共服務平臺項目(2021019611)