Biosimilars: how similar?
Biosimilars: how similar?
复制标题
生物仿制药：有多相似？
DOI：
10.1111/imj.12292
复制
发表时间：
2014
影响因子：
2.1
通讯作者：
Cronstein,B
中科院分区：
文献类型：
--
作者：
Strand,V;Cronstein,B
随着用于治疗风湿性疾病的生物制剂的专利到期，我们有机会开发非专有生物制剂，生物仿制药。这些药物的开发和批准对制药和监管机构都提出了新的挑战，尽管用于治疗风湿性疾病的高质量、较便宜的生物制剂有很大的前景。在这里，我们回顾了生物仿制药的定义，批准这些药物的监管挑战以及迄今为止批准生物仿制药的记录。
As patents expire on biological agents for the treatment of rheumatic diseases, we have the opportunity to develop non‐proprietary biologic agents, biosimilars. The development and approval of these agents present novel challenges to both pharma and regulatory agencies although there is great promise of high quality, less expensive biologic agents for the treatment of rheumatic diseases. Here, we review the definitions of biosimilars, the regulatory challenges to approval of these agents and the record of approvals of biosimilars to date.