企业开展仿制药一致性评价工作的应对策略

Enterprises' coping strategies for generic drugs consistency evaluation

一致性评价工作面临着时间紧、任务急、历史遗留问题多,产业链配套不全,以及巨额投入等多重困难。如何直面困难,赢得这场战役是每一个制药企业必须思考的问题。最终能够通过一致性评价,实现与原研产品同等质量层次的产品,其市场份额必将大幅增量、扩容。本文将从企业角度出发制定一致性评价总体思路、梳理品种、分析存在问题,并制定相应应对策略,以供同行借鉴与参考。

The consistency evaluation for generic drugs is confronted with multiple difficulties,such as tight schedule,urgent task,multiple historical issues,incomplete industry chains,as well as the huge investment. How to confront these difficulties and win this battle have become questions that every pharmaceutical enterprise has to cogitate. Eventually,throughout the consistency evaluation of generic drugs,enterprises are able to endue their products of the equal quality as the original drugs.Their market shares will be greatly expanded. This article will,from perspective of the enterprises,develop the overall idea for the consistency evaluation,review the drug products and analyze the existing problems.Also the corresponding strategies will be developed for pharmaceutical colleagues＇ references.