生物类似药与改良创新生物药的产业态势对比分析  

Comparative Analysis of the Industry Status & Trend between Biosimilars and Biobetters

作　　者：韩佳 郑晓南 HAN Jia;ZHENG Xiaonan(School of Science,China Pharmaceutical University,Nanjing 210009,China;Department of Journal Editorial,China Pharmaceutical University,Nanjing 210009,China)

机构地区：[1]中国药科大学理学院,江苏南京210009 [2]中国药科大学期刊编辑部,江苏南京210009

出　　处：《药学进展》2018年第6期439-449,共11页Progress in Pharmaceutical Sciences

摘　　要：伴随监管政策法规的日趋成熟以及各利益相关方对生物类似药与改良创新生物药的逐渐接受,对生物类似药与改良创新生物药这2类生物药的产业态势有一个清晰全面的了解,有助于生物制药企业制定合理的投资合作发展战略,从而促进其生物药研发和参与区域或全球市场竞争。在对生物类似药与改良创新生物药作清晰定义后,从主要国家或区域市场的研发进展、竞争格局、优劣势以及风险与价值等角度对生物类似药与改良创新生物药的产业态势进行对比分析,以期为相关机构在生物制药行业开展研发、合作、投资、市场活动的发展战略制定与实施提供基于竞争情报的决策支持。With the increasing maturity of regulatory law policies and the gradual acceptance of biosimilars and biobetters by stakeholders, a clear and comprehensive understanding about the industry status trend of biosimilars and biobetters is beneficial for biopharmaceutical companies to map out reasonable development strategy for investment and cooperation and thus promote their RD of biologics and participation in the competition in regional or global market. In order to provide relevant organizations with effective decision-making support based on competitive intelligence for the strategy formulation and implementation of RD, investment and cooperation in biopharmaceutical industry, this paper firstly made a clear definition and introduction of biosimilars and biobetters, then comparatively analyzed the industry status trend of biosimilars and biobetters from the perspectives of RD progress, competitive landscape, advantages disadvantages, and risk value in major countries or regional markets.

关 键 词：生物类似药 改良创新生物药 研发进展 竞争格局 对比分析 

分 类 号：R97[医药卫生—药品]