已上市生物制品的重复申报情况浅析

Analysis of repeated applications of approved biological products

国产药品在过去曾有重复申报现象突出、企业低水平创新的问题。为更好地引导药品合理申报、避免市场药品同水平重复、防止研发投入风险和促进药品产业健康发展,NMPA近些年连续发布了多个指导性文件,对同品种规格过多和重复申报等问题进行约束和引导。在一系列政策的引导下,我国药品注册申报数量大幅下降,申报结构明显改善,逐渐回归理性,但生物制品目前仍存在大量重复申报的情况。本文主要对历年获批上市生物制品的重复情况进行汇总分析,为我国生物制品的监管和企业决策提供参考。

Repeated application of domestic drugs used to be a prominent issue in China,together with the low-level innovations by pharmaceutical enterprises. NMPA has,by issuing a number of guidance documents in recent years,restricted and provided guidance regarding such issues as an excess of strengths for the same variety and repeated applications,in a bid to better guide rational applications of drugs,avoid repetition of drugs at the same level in the market,prevent R&D investment risks and facilitate the healthy development of pharmaceutical industry. A rational return has been seen in China under the guidance of a series of policies,e. g.,a marked decrease in the number of drug registrations and applications,and obvious improvement in the application structure. Despite these efforts,repeated applications of biological products persist at present. Herein,we mainly summarized and analyzed the repetition status of approved biological products for marketing in recent years,thereby providing reference for the supervision of biological products and decision-making of enterprises in China.