全球生物仿制药市场的发展困难与机遇

Global biological generic drugs market's development difficulty and opportunity

目的:探讨发展生物仿制药的途径与策略。方法:分析发展生物仿制药的技术难题与商业障碍,结合现实状况讨论全球生物仿制药市场的机遇。结果:发展生物仿制药不同于传统仿制药,其技术壁垒高,短期商业回报慢,但专利药到期与节约医疗成本的需求使得生物仿制药市场的发展非常迅速,潜力巨大,制药公司可以通过改变一些运作模式来抢占这个市场。结论:发展生物仿制药需要强大的技术研发能力、市场营销能力、资金实力、网络运作能力与生产控制能力,大型制药公司在生物仿制药市场可能会更有竞争力。

OBJECTIVE：To discuss the approaches and s trategies of developing biosimilars.METHODS： Technical problems and commercial barriers of developing biosimilars were analyzed,and opportunities for global biosimilar market were discussed based on the current situation.RESULTS： Unlike traditional generics,biosimilars were characterized by high technical barriers and less short-term commercial return,however,as the patent of brand drugs expired and the demand for medical cost saving increased,the biosimilar market has been making rapid growth with great potential,so that pharmaceutical companies would be able to seize the market by shifting their business model.CONCLUSIONS： Strong RD capabilities,marketing capabilities,financial strength,network management and operation capabilities and production control capabilities are required to develop biosimilars.Large corporations might be more competitive in the biosimilar market.