Nuggets 139 billion U.S. dollars of Chinese pharmaceutical companies market gene
In the global pharmaceutical market, the original research and medicine are multinational pharmaceutical giants reflect the competitiveness of the most important weight. However, relative to high R & D costs and time costs, the domestic Pharmaceutical Industry Can not be grappling with the international pharmaceutical giant, original research and medicine, and face the upcoming release of 139 billion U.S. dollars Generic Market, the domestic pharmaceutical companies can not wait for their demise. Domestic pharmaceutical companies about the chances of where? What they will encounter obstacles and difficulties?
"If you can not beat your enemy, then join them."
Then the international patent expires drug concentration in recent years, was walking on the path in the original research to the international pharmaceutical giant, generic force, or the generic drug business out of the high level of brand imitation, and imitation of the characteristics of combined road record? ? It now appears that both sides of the team, are still crossing the river by feeling the stones.
The world's leading pharmaceutical and healthcare industries Consulting companies IMSHealth U.S. data: the global generic Sell In the sustained sales momentum in the past 12 months?? Japanese generic drug sales increased 10.2%, France 16.9%, Italy increased by 12.5%, Spain 10.5% increase. Currently the world's top ten manufacturers of generic drugs account for 47% of the market, which occupies the top three manufacturers significant advantages, Teva 11%, Novartis Hill's 9%, Marin (Mylan) 8%.
IMS statistics, in 2012, there will be 139 billion U.S. dollars of branded drugs lose patent protection, generic drug industry will bring tremendous business opportunities.
1 "same as" real mechanism for the elimination
First Financial Daily: National Food Drug Administration (SFDA) in 2010 prior to the work of the meeting, that "the strict approval of generic drugs with fake drugs were identical, repeated low-level problem solving", which is currently imitation of the Chinese pharmaceutical [3.98 -0.50%] Industry by?
Li Guoqing: rigorous review of the proposed ideas is not just for the generic drugs, such as "new drugs should be effective, reform must be clear clinical formulations superiority", but the generic drug is one of the key concerns link?? requirement is "whether new drugs or generic drugs, the essential requirement to be innovative," which is a new drug registration and regulation system of the core ideas. Of course, the enterprise will increase costs and risks of research, it is also one of SFDA regulatory purposes, so the ability to continue to do business, do not have the power as soon as possible delisting.
Shuguan Wen: A few years ago we lower the threshold for drug approval, more than the number of drugs for approval, such a low level of the pharmaceutical industry quality and safety of repeated easily lead to hidden dangers on the one hand, more importantly, the agents always "get out to . " Improve the threshold now is hope that the relevant government departments to strictly administrative approval threshold to control the industrial structure and level.
Wang Jin: As a strategic consideration of the national level, raising the threshold is necessary and will surely promote industrial development. But I am worried, I am afraid that many companies still do not recognize the seriousness of the situation of this policy. Although the "same" refers only to a certain range of bioequivalence, dissolution, disintegration, stability, and other indicators of relative "identical", but in reality, it is very difficult to present, many domestic enterprises in technology levels, probably can not make come.
Zhu Kuang good: For business, make "same" would be very difficult, which in fact is the cost of research and high demands are made. Before approval is like to get a license number, only a part of the terminal passed the inspection; stress indicators now meet the standard, in fact, in the development process to control, promoting the role of pharmaceutical development is obvious. Meanwhile, as a company, we also hope that the state standards to control more with reality, and the tightening of policy between the open to find a reasonable "middle value."
2 of the original research and drug companies rush to the field of generic drugs
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