The consistency evaluation of double weight varieties has passed 3 enterprises! Zhengda Tianqing, Haizheng, Xiansheng and other first-hand opportunities, which varieties will be more than 3?

On July 26, the State Drug Administration issued the announcement that the fifth batch of montmorillonite and other 16 varieties and specifications passed the conformity evaluation of quality and efficacy of generic drugs On the same day, it also issued the catalog of generic reference preparations (the 16th batch) According to statistics, 1074 product specifications of 15 batches of reference preparations have been published before; 41 drugs and 25 varieties have passed the consistency evaluation in the first four batches, including 12 varieties in 289 catalogue and 10 varieties In addition to the fifth batch announced this time, 57 acceptance numbers have passed the consistency evaluation In the new batch list, a total of 8 varieties (involving 16 product specifications) passed the consistency evaluation, and products of Xiansheng pharmaceutical, Jiangsu Haosen, Zhejiang Haizheng, Shiyao group, Yangzijiang pharmaceutical, etc were listed It has been approved to pass the generic drug quality and efficacy consistency evaluation catalogue (the fifth batch) At present, it is only 5 months before the enterprise completes the quality and efficacy consistency evaluation of 289 generic drugs With the coming of the time limit, the policy dividend through consistency evaluation is gradually reflected For the varieties that did not complete the evaluation according to the regulations, it is reported that the relevant management department will announce the disposal plan for the failed varieties in August September According to the insight database searched by the reporter of pharmaceutical economic news, as of July 26, the number of acceptance of consistency evaluation undertaken by CDE has reached 261, with a total of 107 varieties, involving 111 enterprises The top 10 varieties in the application acceptance number of consistency evaluation were amlodipine, rosuvastatin, metformin, amoxicillin, irbesartan, cefuroxime, ceftriaxone, entecavir, escitalopram and montmorillonite 2 3 enterprises have passed through Since the launch of generic drug conformity assessment, pharmaceutical companies have been quick to fight for the top three According to the previous opinions on the consistency assessment of generic drug quality and efficacy (February 2016) issued by the state office, "more than three manufacturers of the same type of drugs have passed the consistency assessment, and no more varieties that have failed the consistency assessment will be selected in the centralized purchase of drugs." It is worth noting that up to now, in the first five batches of conformity evaluation list, there have been three manufacturers of rosuvastatin calcium tablets and montmorillonite powder that have passed the conformity evaluation, and the total market space of these two varieties is close to 10 billion According to the data of minenet, the total sales of rosuvastatin calcium tablets in the terminals of public medical institutions and urban retail pharmacies in China in 2017 was 5.839 billion yuan In addition, according to the statistics of yaochunqiu, the original research enterprise AstraZeneca accounted for 68.7% of the market share Although it has passed three enterprises, the latecomers keep pace In addition to Zhengda Tianqing, Jingxin and Haizheng, the enterprises applying for the consistency evaluation of rosuvastatin calcium tablets also include Nanjing Xiansheng Dongyuan Pharmaceutical Co., Ltd and Lek pharmaceuticals D.D., a subsidiary of Sanders Nanjing Xiansheng Dongyuan Pharmaceutical Co., Ltd was undertaken earlier than Laike Pharmaceutical Co., Ltd and is expected to pass the consistency evaluation faster In addition, rosuvastatin calcium tablet of Lunan Beite pharmaceutical has completed be test at the end of last year The official website of Lunan pharmaceutical released information on May 15 Anda of rosuvastatin calcium tablet of the group was approved by FDA of the United States According to relevant regulations, the generic drugs approved by domestic pharmaceutical companies in the EU, the United States or Japan shall be deemed to pass the conformity evaluation after being reviewed and approved Montmorillonite powder is developed by Ipsen pharma In 2017, the total market size of montmorillonite powder in China was about 3.915 billion yuan, of which, the original research enterprise, yipusheng, accounted for nearly half of the market, and Xiansheng pharmaceutical industry ranked second, with a market share of 15.51% The remaining market was divided by more than 40 enterprises At present, Xiansheng pharmaceutical, Sichuan Weiao pharmaceutical and Yangzijiang pharmaceutical have passed the consistency evaluation According to GBF (2016) No 8 document, the consistency evaluation of the same varieties of other drug manufacturing enterprises shall be completed within 3 years in principle after the first varieties pass the consistency evaluation; if they fail to complete the evaluation within the time limit, they shall not be registered again The enterprises that take the lead in passing have the advantages of policy support such as direct online connection and preferential purchase in a short period of time, which is a gradual replacement process for the original research According to the analysis of the industry, in the long run, it is inevitable that there will not be a single company, but also the cooperation of marketing and other dimensions According to the statistics of medical economic news, at present, the varieties that have passed the consistency evaluation of the two enterprises include cefuroxime ester, irbesartan hydrochlorothiazide tablets, irbesartan tablets, tenofovir dipivoxil fumarate tablets, escitalopram oxalate tablets, amlodipine besylate tablets, entecavir dispersible tablets, atorvastatin calcium tablets and captopril tablets Enterprises that fail to pass the consistency evaluation of these varieties should speed up Focus: bidding, procurement and price for generic procurement have been vigorously promoted and clearly defined at the national level this year On April 3 this year, Article 9 of the opinions on reforming and improving the supply guarantee and use policy of generic drugs (GBF [2018] No 20) issued by the State Council requires that "the centralized purchasing agency of drugs shall prepare the purchasing catalogue according to the generic name of drugs, so as to promote the equal competition between generic drugs and original drugs consistent with the quality and efficacy of the original drugs" Policy support for local drug production has also made great progress According to the previous review of pharmaceutical economic news, as of May 30, 2018, Shanghai, Jiangsu, Shanxi, Shaanxi, Inner Mongolia, Ningxia, Jilin, Guangxi, Liaoning, Hubei, Zhejiang and other provinces have clearly issued special procurement policies for the varieties through consistency evaluation, among which, Hubei, Shanghai and other provinces and cities directly purchase online without additional conditions In terms of price, most provinces still hold a "price limit" attitude towards varieties evaluated through consistency, and it is expected that there is limited space for price increase through varieties According to the medical economic daily, Jiangsu, Shanxi and Zhejiang require enterprises to promise that the sales price of the product is not higher than that of other provinces Shaanxi takes the average price of the lowest three provinces and the low value of the current online price of Shaanxi as the limit price, while Guangxi takes the average value of the shortlisted price of the lowest five provinces as the online reference price After the varieties that meet the price requirements are put on the Internet, the medical institutions shall negotiate and purchase independently Shanghai's sunshine platform provides purchasing price information of other provinces and cities, this city and the same variety as a reference for price negotiation, and sets price negotiation reminders for the varieties with large increase or high price In Ningxia, through the consistency evaluation, the products are directly purchased on the Internet, and the maximum price limit of drugs and its relevant regulations are abolished Enterprises can independently declare the product price according to the reasonable market price of products Experts believe that this measure in Ningxia may be the first breakthrough to evaluate the price rise of varieties through consistency evaluation