专家深度访谈:与仿制药相比,原研药的优势有哪些?——以阿卡波糖为例

Depth Interviews: Approaches to Advantage of Branded Drugs over Generic Drugs

目前,我国正处于新一轮医改大潮之中,无论是医疗还是药品革新工作均进行得如火如荼。其中,仿制药一致性评价剑指国产药品质量隐患,波及范围广,是新医改的重要组成部分。国家食品药品监督管理总局(CFDA)已发布关于仿制药质量和疗效一致性评价的系列文件,以指导开展相关工作。而原研药除具备严格的生产工艺和管理流程外,还具有丰富的临床证据和严密的上市后药物安全性监测,让医生和患者使用起来都充满信心。本访谈以阿卡波糖为例,拟从专家的角度分析原研药和仿制药的主要区别。

Nowadays,a new round of health care reform is sweeping across China.Reform the medical care and pharmaceuticals is on the way.Herein,quality consistency evaluation for generic drugs has been wildly challenged and questioned,which constituted the new part of health carereform.China food and drug administration(CFDA)had issued the serial documentation on quality consistency evaluation for generic drugs toinstruct the related reforms.Furthermore,there is not only rigorous production process and management process of Branded drugs,but also extensiveclinical evidence and strict postmarketing safety monitoring,which contribute to confidence of both clinician and patients.This interview will employacarbose to demonstrate and differentiate the advantage of branded drugs over generic drugs,just from the perspectives of experts.