Three "wolves" of domestic generic drugs are coming!

First, a large number of original research has been turned into real estate; second, generic drugs have been put on the market in Europe, the United States and Japan; third, a large number of overseas new drugs In 2017, the way for China's pharmaceutical industry to connect with the world is faster than expected, and the consistency evaluation of generic drugs is becoming more competitive as the threshold for policy loosening is lowered A large number of original research to real estate, generic drugs co listed in Europe, the United States and Japan, and a large number of overseas new drugs simultaneously listed in China will have a huge impact on domestic generic drugs Expired original research drug: no consistency evaluation is required for the original research to be developed On June 9, CFDA General Administration issued two drafts for comments on the announcement of conformity assessment of generic drugs quality and efficacy, which was regarded as a signal of CFDA General Administration's adjustment of conformity assessment policy -- the high requirements of conformity assessment policy previously formulated by CFDA General Administration, which made it difficult for domestic enterprises to implement In order to solve the above difficulties, CFDA made relevant policies Adjusted Take the reference preparation as an example The selection sequence of reference preparations is adjusted as follows: (1) original research drugs: imported original research drugs, drugs produced and listed by original research enterprises in China, but not imported original research drugs; (2) when the original research enterprises stop production, drugs approved and listed by the United States, Japan or the European Union and obtained the status of reference preparations can be selected At the same time, "original research enterprises in China to produce listed drugs" (that is, the original research of real estate products) has been raised to the status of "original research drugs" In addition to the rise of the status of the original research products, the process of consistency evaluation is also simplified: if there is no significant change and the quality and efficacy of the original research products have no difference, there is no need to carry out consistency evaluation In the announcement on the issues related to the evaluation of quality and efficacy consistency of generic drugs, the announcement on the implementation of the relevant issues of the opinions of the general office of the State Council on the evaluation of quality and efficacy consistency of generic drugs originally stated that "consistency evaluation shall be carried out for the real-estate varieties of the original research drugs", which was revised to "classified treatment according to the change situation: it belongs to the category that has not occurred a large amount after listing" If there is a change, or there is a major change after the listing, but the quality and efficacy are not affected after the review, the reference preparation can be selected after the review and verification by the food and drug administration If there are significant changes after listing and there are differences between the quality and efficacy of the same product in the country of origin, the enterprise shall issue a statement to the society within 30 days after the issuance of this announcement, stating the differences and reasons, and carry out conformity evaluation according to the requirements " The process of the original research into real estate is simple and beneficial to the original research into real estate manufacturers in a short term In the long run, the original research products with expired patent still have to face the reform of bidding policy after consistency evaluation of domestic manufacturers, and release part of the market to the domestic manufacturers with consistency evaluation Domestic generic drugs: the cost war officially started to support the implementation of China's domestic enterprises to produce drugs approved for listing in the European Union, the United States or Japan in 2017 As of June 12, 2017, a total of 23 acceptance numbers shown in Table 1 have obtained the "application for drug registration to be included in the priority review procedure" for the reason of domestic co production and listing in Europe, the United States and Japan, including 12 acceptance numbers in 2017 Table 1: the list of double reports to be included in the priority review (data source: sensitive information) of petrochemicals and dongyangguang are the most manufacturers that have obtained the products of "drug registration application to be included in the priority review process" The corresponding products of Ouyi Pharmaceutical Co., Ltd of Petrochemicals Group include metformin hydrochloride tablets, metformin hydrochloride sustained-release tablets and clopidogrel bisulfate tablets Guangdong dongyangguang Pharmaceutical Co., Ltd has clarithromycin tablets, clarithromycin sustained-release tablets and levofloxacin tablets
For the drugs produced by Chinese enterprises approved for listing in the European Union, the United States or Japan but not listed in China, if there is no racial difference confirmed by clinical research, they can apply to the food and Drug Administration (drug review center) for listing using the technical data such as bioequivalence research and pharmaceutical research data declared for listing abroad; if there may be racial differences, they should be opened The corresponding clinical trials were carried out This indicates that the drugs produced by Chinese enterprises approved for listing in the European Union, the United States or Japan but not listed in China are expected to be exempt from clinical direct listing China has entered the WHO organization and intends to join the ICH In the next step, it is likely to open the same preferential policies to the generic drugs listed in Europe, the United States and Japan Or allow the domestic manufacturers to obtain the generic technology authorization of the listed manufacturers in Europe, America and Japan (not owned by Chinese citizens), as long as they are recognized by the listed countries, they can enjoy the policy of common line double reporting For domestic manufacturers, the competition in generic pharmaceutical market is fierce On the one hand, the project cost of domestic conformity assessment drugs has been high (the overall investment of the project is more than 10 million yuan); on the other hand, domestic co production and varieties listed in Europe, the United States and Japan will get the first chance in this conformity assessment competition The policy changes of generic drugs will affect the competition pattern of generic drugs In any case, the cost war is the competition direction of generic drugs in the future Domestic enterprises must start to work out an account - for small and medium-sized enterprises, is it to buy consistency evaluation projects of third-party R & D institutions with risks, or to build their own R & D team by trial and error? Or acquire overseas technology and API through overseas M & A? Which of these paths is more reasonable in cost and time? From the perspective of market structure, as long as there is enough profit space, no policy protection such as first copy and reasonable time for registration and approval, it is difficult to see the situation that the actual number of generic pharmaceutical manufacturers with considerable market scale is less than 3 in the future As long as it is a good product, there will be manufacturers competing for it Cost control will be an important required course that every generic manufacturer must learn in the future Looking forward to the prosperity of new drug value investment, policy reform is conducive to innovation as a whole The fierce competition pattern of generic drugs and the difficulty of overseas market access make the industry be forced to learn to introduce new drugs and carry out the first drug project quickly without preparation The author is more puzzled about whether the "me too" medicine, which has not lost in the past, can continue to have good performance after the market competition intensifies? The success rate of new drug projects in innovative drugs, especially in domestic research institutions, is low, and domestic enterprises dare not invest in them In order to pursue the success rate, once the policy of accepting foreign data is implemented, domestic enterprises will more actively introduce mature new drug projects from overseas, and buy off domestic rights and interests of overseas new drugs are solutions At present, the reward mechanism of new drugs overseas is difficult for most small and medium-sized domestic pharmaceutical enterprises to bear The key to the evaluation of new drug project is the clinical value of drugs, which is often based on the clinical trial data China has been engaged in the development of generic drugs for a long time and lacks experienced personnel in clinical trials of new drugs If enterprises want to establish a new drug system, it will be a general trend in the short term to guide the high salary return of overseas Chinese scientists.