生物类似药评价

发布时间：2018-02-16 20:47

本文关键词： 生物药用药需求临床优势仿制药技术指导原则国际热点类药品 approval 生物制药产业 biologic 　出处：《药物分析杂志》2015年05期 　论文类型：期刊论文

【摘要】：正[编者按]生物类似药是继原研生物制品之后进入市场,在安全性、纯度和效价上与原研生物制品具有高度相似性的新药物。由于生物药在治疗某些严重威胁人类健康疾病时具有明显的临床优势,以原研生物药质量、安全性和有效性为基础的生物类似药的研发,不仅可以降低生物药研发失败的风险和经费,也有助于提高生物药的可获得性,满足病人用药需求,故而受到广泛的青睐,成为当前的一个国际热点。但是,与小分子仿制药的单纯复制不同,生物类似药仅是高度相似,而非完全相同的高度复杂的大分子
[Abstract]:Bio-analogous drugs enter the market after the original biological products, and in safety, New drugs with high similarity in purity and titer with original biological products. Because biological drugs have obvious clinical advantages in the treatment of certain serious diseases that threaten human health, the quality of the original biological drugs is used. The research and development of similar biomedical drugs based on safety and effectiveness can not only reduce the risk and cost of the failure of the research and development of biological drugs, but also help to improve the availability of biological drugs and meet the needs of patients. It has become an international hotspot. However, unlike the simple replication of small molecular generic drugs, biological analogues are only highly similar, not identical, highly complex macromolecules
【分类号】：R95

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