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    Home > Active Ingredient News > Drugs Articles > Over the past year, the global R & D line of bio generic drugs has expanded by 40%

    Over the past year, the global R & D line of bio generic drugs has expanded by 40%

    • Last Update: 2014-05-04
    • Source: Internet
    • Author: User
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    Source: Ding Xiangyuan's research data from decision resources on May 4, 2014 shows that in the past 12 months, the number of biosimilars development projects publicly disclosed in the world has increased by 40% Most of these projects have not yet entered the clinical development stage, but the 20% annual growth rate of biomimization in the clinical trial stage also shows the substantial progress of the later product development line South American companies have the largest growth in the number of biosimilars developed Indian companies have revealed more bionic developments Among the developers, monoclonal antibodies such as rituximab and trastuzumab have undoubtedly become the most popular targets, largely due to the huge sales of its brand drugs and the coming patent expiration in the main market Although regulatory guidelines for biosimilars have been adopted in more than 60 countries so far, "we are still a long way from global coordination," said Kate keeping, senior director of biosimilars at decision resources "Biosimilars manufacturers face many challenges, such as pre production costs, proving bioequivalence, designing clinical trials to meet changing regulations, and easing physicians' concerns about the similarity and product differences of biosimilars compared with the original brands." The study found that a number of biosimilars manufacturers are developing new clinical development strategies, such as dividing phase 1 clinical trials into three trial groups, including reference preparations from the United States and the European Union, so as to reduce risks and simplify product processes At present, a large number of partnerships show that it is a very complex process to bring a biosimilars from the laboratory to the global market, and the reward for success is to have a certain sales share in the United States, Japan, Germany, France, the United Kingdom, Italy and Spain The market share of biosimilars in these countries is expected to exceed 19.5 billion US dollars by 2022, Decision resources Link to the original text: http://
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