我国生物仿制药发展现状与策略研究

Study on Status and Countermeasures about Biosimilars in China

随着生物药专利失效期到来所带来的成本降低、药物可及性增加及巨大市场空间等因素影响,各大企业对生物仿制药的开发表现出浓厚的兴趣,纷纷涉足这一领域,然而由于生物仿制药的特殊性,开发及产业化困难重重。基于以上背景,首先分析了国内外生物医药行业宏观经济环境、行业政策环境、法律监管环境等外部环境,然后对当前生物仿制药开发存在的关键性技术共性问题进行了阐述。在此基础上对国内外主要生物仿制药企业现状进行分析,提出了我国与国外生物仿制药方面存在的主要差距。在上述分析的基础上,利用SWOT工具进行战略分析,指出我国生物仿制药应该执行的SO战略为主,SW战略为辅的策略。最后提出了一些参考建议。

As the number of biological patents are about to expire,with the affection about drug cost reducing,availability increasing and a huge market space and so on,there showed great interest on developmenting biosimilars,major companies have set foot in this area,however because of specificity of biosimilars,success is not so easy.Based on the above background,the external environment,the macroeconomic environment,policy environment,legal and regulatory environment of the domestic and international bio-pharmaceutical industry are analyzed,then the current key technology problems of biosimilar developed are described.Based on this,the main ga Pabout biosimilar companies between demestic and abroad is proposed.Based on the above analysis,SWOT analyze the strategy and proposes that China should be carry out SO strategy mainly and supplements with SW strategy is used.Finally,some suggestions are for reference.