生物仿制药警戒计划的制订

Formulation of Pharmacovigilance Plan of Biological Generic Drug

目的:按照药物临床安全性和警戒性的要求,对生物仿制药的生物利用度、临床疗效安全性进行评价,以制订生物仿制药警戒计划。方法:对我国生物仿制药在前期研究、临床试验、生产等过程存在的问题进行分析。结果与结论:生物仿制药品相似但不相同,生物制剂生产过程复杂,容易出现变异,有必要进行临床安全性评价。国家各卫生医疗机构部门应高度关注,加强药品的自检、抽检、监督管理,在生物仿制药使用过程中发现问题,提高我国生物仿制药的临床安全用药水平。

OBJECTIVE： To evaluate bioavailability and safety of clinical efficacy of biological generic drug according to the requirement of drug safety and pharmacovigilance, and to formulate the pharmacovigilance plan for it. METHODS： Problems of biological generic drug in China were analyzed in terms of preliminary study, clinical trial and production. RESULTSCONCLUSION： Biological generic drugs are similar but not same, and the production process is complex and easily results in variable. It is necessary to evaluate clinical safety of drugs. Medical institutions should be intensely focused on self-checking, sampling inspection, supervision and management, find out problems to improve safety of biological generic drugs in China.