Page 14 - 《中国药房》2021年07期

·药事管理·

美国生物药上市后风险管理及对我国的启示 Δ

李梦颖 ，王峻霞，蒋 蓉（中国药科大学国际医药商学院，南京 211198）
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中图分类号 R951；S859.79+7 文献标志码 A 文章编号 1001-0408（2021）07-0776-06
DOI 10.6039/j.issn.1001-0408.2021.07.02
摘 要 目的：借鉴美国生物药上市后风险管理经验，为我国生物药上市后风险管理提供参考。方法：通过研究美国FDA发布的
指南文件、网站信息等资料，对美国生物药上市后风险管理进行分析，并以英夫利昔单抗为例介绍其具体实施情况，总结其管理特
点并提出对我国生物药上市后风险管理的启示及相关建议。结果与结论：美国生物药上市后的风险管理主要包括“风险评估与降
低策略（REMS）”“上市后研究和临床试验制度”两方面，其中后者包括上市后要求（PMR）和上市后承诺（PMC）两类。以英夫利昔
单抗为例，该药自1998年8月被美国FDA批准上市后，其生产厂家于2009年向FDA提交了REMS并获批，并先后5次提出上市后
研究和临床试验。可知美国生物药上市后风险管理是由FDA通过出台具体指南，鼓励多角色参与风险管理，实现与患者的有效
沟通，对生物药风险进行持续监管，以降低生物药的使用风险。对于生物药而言，我国尚未制定系统、具体的实施细则和指南，在
上市后风险管理方面仍存在欠缺。建议我国可借鉴美国对生物药上市后风险管理的措施和制度，尽可能吸纳利益相关方参与上
市后管理，通过与患者进行有效沟通以提升患者用药风险意识，并且进一步完善上市后研究管理制度，保障患者用药安全。
关键词 美国；生物药；上市后风险管理；启示

Post-marketing Risk Management of Biopharmaceuticals in the United States and Its Enlightenment to
China
LI Mengying，WANG Junxia，JIANG Rong （School of International Pharmaceutical Business， China
Pharmaceutical University，Nanjing 211198，China）

ABSTRACT OBJECTIVE：To learn from the experience of post-marketing risk management of biopharmaceuticals in the United
States，and to provide reference for post-marketing risk management of biopharmaceuticals in China. METHODS：By studying
guidance documents and website information issued by FDA，the risk management of biopharmaceuticals after marketing in the
United States was analyzed. Taking infliximab as an example， the specific implementation situation was introduced， the
management characteristics were summarized，and the enlightenment and relevant suggestions were put forward for the risk
management of biopharmaceuticals after marketing in China. RESULTS & CONCLUSIONS：The post-marketing risk management
of biopharmaceuticals in the United States mainly includes two aspects as“risk evaluation and mitigation strategy（REMS）”and
“post-marketing study and clinical trials system”. The latter included post-marketing requirement （PMR） and post-marketing
commitment（PMC）. Taking infliximab as an example，since it was approved by FDA in August 1998，its manufacturer submitted
REMS to FDA in 2009 and obtained approval，and proposed post-marketing studies and clinical trials for five times. It can be seen
that FDA has issued specific guidelines for post-marketing risk management of biopharmaceuticals to encourage multi-role
participation in risk management， realize effective communication with patients， and continuously supervise the risk of
biopharmaceuticals，so as to reduce the risk of the use of biopharmaceuticals. For biopharmaceuticals，China has not yet formulated
systematic and specific implementation rules and guidelines，and there is still lack in post-marketing risk management. It is
suggested that China can learn from the measures and system of post-marketing risk management of biopharmaceuticals in the
United States，involve stakeholders in post-marketing management，enhance patients’awareness of drug use risks through effective
communication，and further improve the post-marketing research management system to guarantee patients’safety of drug use.
KEYWORDS United States；Biopharmaceuticals；Post-marketing risk management；Enlightenment

自 1982 年全球首个生物技术药物重组胰岛素上市
Δ 基金项目：江苏高校哲学社会科学研究项目（No.2019SJA-
0059）；中 国 药 科 大 学“ 双 一 流 ”学 科 创 新 团 队 建 设 项 目（No. 以来，经过近40年的发展，目前已有细胞因子、重组酶和
CPU2018GY40） 激素、单克隆抗体、融合蛋白、基因治疗药、细胞治疗产
＊本科生。研究方向：医药政策与法规。E-mail：limengying_ [1]
品和基因工程疫苗等 200 多种生物药上市 ，这些生物
121@163.com
药在癌症和遗传性疾病等诸多严重疾病的治疗中发挥
# 通信作者：讲师，博士。研究方向：医药政策与法规。E-mail：ji-
angr_0_0@163.com 着重要且关键的作用。与一般小分子化学药相比，生物

·776 · China Pharmacy 2021 Vol. 32 No. 7 中国药房 2021年第32卷第7期