It is not easy for foreign capital to recruit high-quality generic drugs and sink into the grass-roots level to exchange price for quantity

Source: pharmaceutical economic news 2014-09-17: strategies for foreign enterprises to extend drug life cycle and improve product imitation barriers, which can be used for reference by domestic enterprises "“ The quality consistency evaluation of generic drugs can be said to be the government's recognition that there are different quality problems of the same generic drugs in China, which is a practical embodiment It will improve the quality and production process of generic drugs in China, complete the technology upgrading, promote the integration of domestic pharmaceutical enterprises, and transform from a big country of generic drugs to a powerful country of generic drugs " Hu Shanlian, director of the Shanghai Research Center for health development and professor of the school of public health, Fudan University, pointed out at the ninth round table on health policy in Shanghai on September 13 Business people believe that standardizing enterprises will be the beneficiaries of the policy Statistics on the decline of foreign market share show that in the past 10 years, the growth rate of global generic market is more than twice that of patent drugs In 2007, the scale of global generic market was US $89 billion In 2013, it expanded to US $172 billion, with an average annual growth rate of 12% From 2014 to 2018, 295 original research patents will expire, and the loss of original research drugs is expected to reach US $19.7 billion In recent years, the imitation strategy of domestic enterprises has changed from simple imitation to combination of imitation and innovation The first imitation medicine of Hengrui, Zhengda Tianqing and other enterprises has brought great pressure to foreign enterprises According to the data provided by the conference, in the second quarter of 2014, the sales volume of Chinese pharmaceutical market accounted for only 24% of that of multinational enterprises In recent quarters, the average growth rate of sales of foreign-funded enterprises is slower than that of the industry, and the market share is expected to continue to decline Influenced by the pressure of medical insurance control, generic drugs are widely used in clinical practice Before that, domestic generic drugs remained more in the "generic standard", rather than the generic varieties, resulting in the clinical "efficacy of domestic drugs is not as good as the original drugs" Researcher Jin Shaohong, senior consultant of international cooperation of CFDA, pointed out that doctors are more willing to use the original research drug at the critical moment of curing the disease and saving people, and the sampling inspection of national drug plan did find that the quality of some domestic drugs is different from that of the original research plant "After the results of quality consistency evaluation of generic drugs are released, generic drugs with excellent quality and effect can narrow the price gap with imported original research drugs, and more easily enter the medical insurance and bidding system of all regions." Dr Han Liling, general manager of tisley international innovation and investment business division, said Although the development of quality consistency evaluation of generic drugs has attracted discussion about the dispute between domestic and foreign enterprises in the industry, it has invested in AstraZeneca (China) According to Wang Lei, vice president of the company, this work is not aimed at foreign enterprises Reviewing a series of government measures, including one product dual regulation and anti drug restriction order, is conducive to standardizing the market, promoting the healthy development of the industry, and truly scientific and reasonable drug promotion companies will benefit It is not easy for Professor Hu Shanlian's research and measurement to change price for quantity The average gap between the price of generic drugs and the original drugs is about 56% In fact, the price of some generic drugs is higher, while others are very low, which is related to GMP, bioequivalence, clinical results and other factors The price increase of high-quality generic drugs will further narrow the price of generic drugs and original research drugs Wang Lei analyzed that the quality consistency evaluation of generic drugs is essentially to encourage high-quality drugs After the elimination of low-quality drugs, this part of the market is a new opportunity for foreign enterprises But these markets are often distributed at the county level or even lower level Foreign enterprises need to sink rapidly, but they also face the problem of exchanging price for quantity If it can be done in a large amount, a certain degree of price reduction is feasible in Wang Lei's view, but the classic case of MSD Shujiang makes many foreign enterprises tangle "The example of Shujiang is not necessarily the most appropriate, but it is more typical." According to the data provided by Wang Lei, Shujiangzhi's sales volume only slightly increased by 2% after the sharp price reduction, which shows that it is not easy to achieve small profits and high sales in the Chinese market, but if the sinking can guarantee the increase of the volume, it is worth trying to exchange the price for the volume Wang Lei pointed out that foreign enterprises have obvious advantages in terms of quality, preparation technology, brand extension, integration with clinical data, integration with drug delivery devices, cooperation with medical device companies, etc., and market norms have more opportunities than challenges for foreign enterprises The above advantages are also the strategies for foreign enterprises to extend the drug life cycle and improve the product imitation barriers, which can be used for reference by domestic enterprises (Li Jia)