Shangyao, Hengrui and China Resources SECCO passed the consistency evaluation! When the policy combination comes, the first batch of products to be eliminated are

If the products fail to pass the consistency evaluation, slow-moving products, or are eliminated by the policy line, or by the market, the time limit is coming And the first thing that generic drugs replace the original research is to reach three varieties through manufacturers Major breakthroughs have been made again through the follow-up favorable policies of consistency evaluation On August 10, Jiangxi pharmaceutical procurement service platform issued the notice on prolonging the procurement cycle of "two envelope" bid winning results and the procurement of drugs on the Internet through the conformity evaluation of generic medicine, stating that For the three products that have passed the conformity evaluation, the online purchasing qualification of the products that have not passed the conformity evaluation shall be suspended, and the dynamic supplement application of the products that have not passed the conformity evaluation shall not be accepted At the same time, the notice also directly announced the suspension of procurement of products of two enterprises, namely, montmorillonite powder of Shandong Xianhe Pharmaceutical Co., Ltd and tinifovir fumarate dipivoxil tablets of Anhui Baker bio These two varieties have reached three enterprises through consistency evaluation, even if they have purchasing qualification in the early stage, they are also directly kicked out The trend of evaluating varieties by consistency and abandoning failed varieties has been surging From the aspects of bidding, purchasing and hospital use, the leaders have taken a clear stand In fact, these policies are the contents of the general office of the State Council's Document No 8 in 2016, which is the framework that has been planned for the top-level design It can be seen that more places will follow this trend in the future and successively issue detailed policies In addition to the recent "scheme on the pilot drug centralized procurement organized by the state", 11 pilot cities were selected at the national level for centralized procurement of generic drugs through consistency evaluation, and a series of detailed rules were used to ensure that the market share reached 60% This is a drug reshuffle led by the will of the state The purpose is very clear, that is to make the products through the consistency evaluation of generic drugs land in the market and replace the original research However, if the products fail to pass the consistency evaluation, slow-moving products, or are eliminated by the policy line, or by the market, the time limit is coming And the first thing that generic drugs replace the original research is to reach three varieties through manufacturers 1 after the first three varieties have been determined to pass the fifth batch of conformity evaluation on July 26, 2018, Shanghai Pharmaceutical's fluoxetine hydrochloride capsule, Hengrui pharmaceutical's ambroxol hydrochloride tablet and Cr Shuanghe's amlodipine besylate tablet have passed the conformity evaluation In addition, GST announced that its application for conformity assessment of entecavir capsule was accepted Amlodipine besylate has always been a big concern in the consistency evaluation, and it is also the largest anti hypertension drug in China In 2017, the scale of amlodipine tablets in China's major end markets reached 7 billion yuan The original research manufacturer is Pfizer's "luohuoxi", which was listed in the United States in 1987 It is a major product of Pfizer, with a global sales volume of 926 million US dollars in 2017 The original manufacturer of ambroxol hydrochloride tablets was bringer Ingelheim (BI), which was approved to be listed in Germany in 1979 In 2017, the terminal sales of public medical institutions in China exceeded 200 million yuan, and Bi accounted for 47% of the market share Hengrui's generic medicine is the first one to pass In addition to Hengrui, Shandong Yuxin Pharmaceutical Co., Ltd is in the process of "under review and approval" and passing soon Fluoxetine hydrochloride capsule is an antidepressant In 2017, the terminal sales volume of public medical institutions in China was 118 million yuan, and the original manufacturer was Lilly, accounting for 47% of the market share Sinopharm, a subsidiary of Shanghai pharmaceutical, is the first enterprise to pass the consistency evaluation of the product At present, no other enterprise has carried out be test, but several enterprises have put the reference preparation of this variety on record In addition, as of August 14, 2018, a total of 69 product specifications have passed the consistency evaluation Among them, there are 3 manufacturers of the same variety and 2 manufacturers of 6 products Table 1: there are three varieties of enterprises that have passed the consistency evaluation: Table 2: there are two kinds of enterprises that have passed the consistency evaluation Since May 2018, the number of consistency evaluation applications accepted by CDE has reached a new high In the second half of the year, the number of the same varieties will be more and more In 2017, the sales volume of tenofovir dipivoxil fumarate tablets in sample hospitals was 240 million, of which GSK, the original manufacturer, accounted for 100% of the market share In 2016, tenofovir's global sales reached US $1186 million Rosuvastatin is the most competitive product In the future, the number of rosuvastatin enterprises that can obtain consistency evaluation marks is likely to reach 8-10 In the first three quarters of 2017, the sales volume of public hospitals in key cities reached 488 million yuan, with AstraZeneca occupying 70% of the market share In the Chinese market, the trend of generic drugs challenging the original drugs has become a foregone conclusion Through the enterprise to reach three varieties to bear the brunt, become the first to be replaced According to the policy arrangement, these original research drugs will have up to 40% of the market share, and the era of occupying more than 80% of the market share in the past will be gone The sales of these large cash flow products in China will be cut back 2 The "gate" of the bidding is closed For the "track" of conformity evaluation varieties, the general office of the State Council issued No 8 document in 2016, which stipulates that in principle, 289 catalog products shall complete the conformity evaluation before the end of 2018, and the varieties not completed before the specified time limit will not be registered again For non 289 products, the enterprise can organize the consistency evaluation by itself After the first variety passes the consistency evaluation, three years later, the enterprise will no longer accept the application for the consistency evaluation of the same variety from other pharmaceutical manufacturers No 8 document does not limit the passing quantity of the same variety at the level of the State Food and drug administration, but only specifies the passing time limit However, in the supporting measures, it is stipulated that if there are more than three manufacturers that have passed the consistency evaluation of the same kind of drugs, the unqualified varieties will not be used in the centralized purchase of drugs This is another "gate" for enterprises in bidding and purchasing The detailed rules that have been issued by the provinces before concentrated on the level of "automatic online purchasing through varieties" Now, with more and more varieties passing through, the number of varieties reaching 3 has gradually increased, meeting the policy requirements, so Jiangxi has launched the first shot, taking the lead in closing the gate, which immediately gives enterprises in line a stronger sense of urgency As of July 28, 2018, 14 provinces and cities have issued online procurement policies, 7 of which have entered the implementation stage At the specific level of implementation, these provinces are likely to follow the example of Jiangxi Province Once the whole country follows the example, the public hospital market will become the world through enterprises, a large number of failed enterprises will quickly lose the public hospital market, and they can only move to other markets such as retail pharmacies Price is the only worry! According to the program on centralized drug procurement pilot organized by the state, the generic drug procurement forms that have passed the consistency evaluation are divided into three types: different procurement forms are implemented according to the number of shortlisted manufacturers and different competition conditions If there are 3 or more shortlisted production enterprises, bidding procurement shall be adopted; if there are 2 shortlisted production enterprises, bargaining procurement shall be adopted; if there is only 1 shortlisted production enterprise, negotiation procurement shall be adopted But before that, more insiders revealed that the State Pharmaceutical bureau plans to adopt the price led volume procurement in the pilot cities, and will compete with the original research drugs in the same platform with the generic drugs that have passed the consistency evaluation As long as the lowest price can be quoted, 70% of the market can be exchanged It is consistent with the 60% - 70% market share promised in the scheme for centralized drug procurement pilot organized by the state Therefore, in the specific implementation process, what kind of approach will be adopted in the pilot city at the national level, what kind of scheme will be issued in the non pilot city, and how to maintain the price system will become the biggest unknown The way of "offer the lowest price" has been hotly discussed by the insiders Some insiders believe that once a price war is launched, enterprises may have no bottom line to lower the price in order to win the bidding qualification, and the consistency evaluation itself will greatly increase the cost of enterprises If there is a price hanging upside down, will there be a situation of Jerry building, good money expelling bad money? Some even think that, in accordance with the price led trend, enterprises may compete with each other like the previous national basic drugs, and finally "work in vain" As a matter of fact, the consistency evaluation is meant to "repay the old historical accounts" The national level believes that this is the mission of the enterprise itself and the task that should be completed Secondly, this is an industry reshuffle led by the national policy One of the ultimate purposes is to change the situation of "small, scattered and disorderly", make a large number of approvals directly withdraw from the market, and reverse the situation of marketing leading and inefficient competition Even in the world, generic drugs are positioned as "high quality and low price", which can replace the original research drugs and save medical expenses So no matter from which level, through the evaluation of the price of varieties are unreasonable But it doesn't mean that there will be price inversion and bad money driving out good money, because the State Food and drug administration has changed the concept of supervision, increased flight inspection, and comprehensively guaranteed the quality and standard of drugs Moreover, as an important part of the whole medical reform, the quality of generic drugs should serve the next deeper medical reform It must be the future trend to replace the original drugs, and it will not fall short At the same time, the multi-dimensional layout of future marketing is particularly important for the enterprises passing the evaluation Even though the scheme on pilot drug centralized procurement organized by the state has designed a series of systems for "volume procurement", ensuring the consumption, the use of generic drugs in medical institutions has been included in the assessment system, requiring the compulsory use of generic drugs For doctors and patients, the level of awareness of generic drugs is still insufficient Even in the United States, it is also stipulated that the use of generic drugs requires the consent of patients, so it is very important to have a good brand awareness at the level of doctors and patients.