【摘要】：目的探討生物類似藥研發(fā)評價的相關(guān)問題。方法結(jié)合《生物類似藥研發(fā)與評價技術(shù)指導(dǎo)原則》(試行)(以下簡稱《指導(dǎo)原則》)的起草工作,從生物類似藥的起源、現(xiàn)行法規(guī)中相關(guān)內(nèi)容、對于生物類似藥的理解、生物類似藥的研發(fā)評價思路、研發(fā)與評價的問題與難點等方面探討交流生物類似藥及候選藥的內(nèi)在特性與研發(fā)風險。結(jié)果與結(jié)論建議參照國內(nèi)頒布的《指導(dǎo)原則》設(shè)計適宜的比對性研究,選擇適宜的研發(fā)路徑,評估論證研發(fā)工藝、生產(chǎn)規(guī)模、研究批次的代表性及合理性,清醒認識比對研究中的技術(shù)要求、相似性評判的難度和復(fù)雜性,慎重選擇和開發(fā)生物類似藥。
[Abstract]:Objective to explore the related problems in the research and development evaluation of biological analogues. Methods combined with the drafting of the Technical guidelines for the Development and Evaluation of Bio-analogous drugs (hereinafter referred to as "the guiding principles"), from the origin of Bio-analogous drugs, the relevant contents of current laws and regulations, and the understanding of Bio-analogous drugs, This paper discusses the inherent characteristics and R & D risks of the communication of biological-analogous drugs and their candidates from the aspects of the ideas of R & D evaluation, the problems and difficulties of R & D and evaluation of biological-analogous drugs. Results and conclusion it is suggested to design appropriate comparative research, select appropriate R & D path, evaluate R & D process, production scale, representativeness and rationality of R & D batch according to the guidelines issued in China. We should be aware of the technical requirements of comparative study, the difficulty and complexity of similarity evaluation, and carefully select and develop biological analogous drugs.
【作者單位】： 國家食品藥品監(jiān)督管理總局藥品審評中心;
【基金】：國家科技重大專項“重大新藥創(chuàng)制”課題資助項目(2015ZX09501008)
【分類號】：R95
，

本文編號：2276981