[Zhou Jun] similar biological drugs are on fire, Samsung enters the Bureau, Qilu and Fuhong Hanlin are going to be on the market soon; Zhuhai Yibang has many problems in flight inspection, production suspension and rectification, and GMP certificate recovery!

The pilot program of national volume procurement through bidding was released The procurement volume, usage and payment collection were guaranteed on January 17 The pilot program of centralized procurement and use of drugs organized by the state was officially released "National organization, alliance procurement, platform operation" has become the main idea of drug procurement in the future After the implementation of centralized procurement in this pilot city, the scope of drug centralized procurement will gradually expand The plan specifically arranges the purchase quantity, use quantity, payment collection guarantee, use guarantee and other aspects The main points are as follows: 1 According to 60-70% of the total annual consumption of the pilot public medical institutions, the total purchase quantity is estimated, and the remaining 30-40% of the consumption quantity, the public medical institutions can still purchase other online varieties with appropriate prices for centralized purchase of provincial drugs; 2 Public medical institutions in the pilot areas should give priority to the use of centralized procurement varieties to ensure the completion of contract consumption within one year; 3 Ensure payment collection, reduce transaction costs, and strictly check the medical institutions' failure to settle drug payments on time On the basis of total budget, medical insurance funds should be prepaid to the medical institutions at least 30% of the procurement amount in advance; 4 The use of the selected drugs shall be included in the performance appraisal of medical institutions and medical personnel All relevant departments and medical institutions shall not influence the reasonable use and supply guarantee of the selected drugs on the grounds of cost control, drug proportion, requirements for drug varieties, specifications and quantities of medical institutions 8-point answer from the director of medical insurance: the purpose and difference of the plan were introduced by Chen Jinfu, deputy director of the State Medical Security Bureau, at the regular policy briefing of the State Council on the day of the official publication of the pilot plan for centralized purchase and use of drugs organized by the state At present, the enterprise is docking with the pilot areas, carrying out networking, preparing goods, and then signing a contract It will be implemented in late March of this year for a period of one year According to the general reform idea of "national organization, alliance procurement and platform operation", the plan aims to achieve four goals: to squeeze out water and reduce drug price; to link quantity and price to reduce unnecessary costs; to guide and standardize drug use and optimize drug use structure; to explore and improve drug recruitment mechanism and market-oriented drug price formation mechanism In addition, there are four basic requirements for this bidding and procurement, which are different from the previous ones: strictly require the procurement with quantity and exchange the price with quantity; strictly require the integration of bidding and procurement to ensure the use; ensure the quality and supply; ensure the collection and reduce the benefit cost Novartis, hausen and Sinopharm failed to negotiate the price, and they can still purchase normally after passing the bidding? On January 15, a notice from Henan public resources trading center caused hot discussion in the industry According to the notice, in the special centralized purchase and price negotiation of anticancer drugs just carried out in Henan Province, imatinib tablets (0.1g) produced by Novartis, Haosen and Ouyi enterprises of petrochemicals were the whole group's flow standard due to "unconfirmed expert's recommended price" According to the relevant regulations of Henan Province, the drugs that are not shortlisted for negotiation in the special centralized purchase of anticancer drugs and are not listed in the limited online purchase will be stopped after February 1, 2019 In other words, imatinib tablets (0.1g) of all manufacturers will be stopped from purchasing and using in half a month However, in order to ensure clinical medication, imatinib tablets (0.1g) produced by the above three enterprises can be purchased and used by medical institutions according to the notice In this regard, some media said that the reason for purchasing the standardized drugs "for the purpose of ensuring clinical medication" could not be fully convincing What do you think of this? Please leave a message Recently, Shandong released the "list of the first batch of generic drugs through consistency evaluation" with a total of 50 product specifications, including several successful "4 + 7-belt procurement" varieties such as entecavir dispersible tablets of Zhengda Tianqing and atorvastatin calcium tablets of Jialin pharmaceutical However, compared with the price, the bid price did not match the bid price of "4 + 7 volume purchase" For example, in the 4 + 7 belt purchase, the median price is 17.36 yuan / box (0.5mg * 14 pieces / plate * 2 plates) of Zhengda Tianqing's entecavir dispersible tablets, and the net price of 28 pieces / box of the same specification packed in Shandong Province is 295.45 yuan; the net price of atorvastatin calcium tablets (20mg * 7 pieces / box) of Jialin pharmaceutical is 39.5 yuan / box, about 6 times of the 4 + 7 median price of 6.6 yuan 34 medicines are on sale! Qilu, Hengrui, Zhengda Tianqing On January 17, the centralized purchase network of drugs and medical consumables of Liaoning Province released the notice on price adjustment of 32 anticancer drugs 28 drugs from 8 pharmaceutical companies actively applied for price reduction and 4 drugs were restored to the network after price reduction Eight pharmaceutical enterprises, including Qilu, Zhengda Tianqing, Wuhan Renfu, Harbin Sanlian, Chongqing Laimei and Jiangsu Hengrui, took the initiative to apply for price reduction Among them, the drugs with a large drop included pemetrexed disodium for injection of Qilu pharmaceutical, the 0.2g standard price was adjusted from 1343.95 yuan to 940.77 yuan, and the 50mg of cisapride for injection was adjusted from 2250 yuan to 2069.99 yuan In addition, Roche and Zhengda Tianqing also applied for price reduction this week Roche Applied in Sichuan to adjust the net price of capecitabine tablets (specification: 0.5g * 12 tablets) from 350.4 yuan to 330 yuan; Zhengda Tianqing applied in Shaanxi to adjust the net price limit of imatinib mesylate capsule (100mg * 60 Capsules) from 872.19 yuan / box to 586.39 yuan / box, with a price reduction rate of more than 30% Market Alert 3 pharmaceutical companies have many problems in testing, stop production for rectification, and take back GMP certificate! On January 18, the State Food and Drug Administration issued a report on the flight inspection and handling results of Zhuhai Yibang Pharmaceutical Co., Ltd., Sichuan Xieli Pharmaceutical Co., Ltd and three pharmaceutical enterprises, including Hubei lvjin Pharmaceutical Co., Ltd., to withdraw GMP certificates and suspend production for rectification The main inspection problems are: clindamycin phosphate for injection, voriconazole for injection and other varieties of Zhuhai Yibang Pharmaceutical Co., Ltd., with multiple batches of products sterile for re inspection; berberine hydrochloride of Sichuan cooperative Pharmaceutical Co., Ltd started production and sales before obtaining the GMP certificate; products of Hubei lvjinzi Pharmaceutical Co., Ltd., such as Ankahuangmin capsule, Tongfengshu tablet, concentrated weiphosphorose syrup and wuweita oral liquid, etc, Since June 2015, the product quality review analysis has not been conducted as required Crack down on medical kickbacks, and the doctor will directly leave the post! On January 16, the Shanghai Municipal Commission of health and Health issued the measures of Shanghai Municipality on the management of scores of doctors' bad practice (for Trial Implementation) (hereinafter referred to as the measures) According to the measures, doctors who have bad practice behaviors in practice will be given points, accumulated to a certain amount, and will be given different penalties if the points exceed a certain standard The scores of doctors' bad practice include 1, 2, 4, 6, 8, 10, 12 and 18 According to the document, doctors' business is unified and they receive kickbacks Once they are found, the highest score is 18 points Once the score of doctors' bad practice reaches 18 points or above, they will leave the post for training for 3 months In addition, they will be given corresponding treatment according to the measures for the management of regular assessment of doctors More than 40 billion bestselling biological products modified the instruction manual Recently, 26 enterprises were affected The State Food and Drug Administration issued a notice to revise the instruction manual of intravenous human immunoglobulin (pH4) and freeze-dried intravenous human immunoglobulin (pH4), mainly adding warning words, and revising the [adverse reactions], [notice items], [elderly medication] and other items Among them, intravenous human immunoglobulin (pH4) is the best-selling product in biological products, ranking second among all batch issued biological products, with a total sales volume of 46.207 billion yuan and a sales volume of 6.247 billion yuan in 2018 There are 26 domestic enterprises holding the approval documents for the production of human immunoglobulin (pH4) for intravenous injection, and Chengdu Rongsheng Pharmaceutical Co., Ltd ranks the highest in the cumulative sales, with a total of 5.622 billion yuan On January 15, Huahai 2 sartan API was suspended from exporting to Europe Huahai pharmaceutical released a notice saying that the European Pharmacopoeia Committee decided to suspend the European Pharmacopoeia adaptability Certificate (CEP) of irbesartan API and losartan potassium API of the company due to the influence of several batches of irbesartan API products detected that the NDEA exceeded the standard, and the risk assessment of sarbesartan API products Other CEP certificates of sartan API products of the company are still valid after evaluation by the European Pharmacopoeia Committee According to the announcement, the amount of two APIs sold to Europe from January to September 2018 was 100.81 million yuan, accounting for 2.62% of the total sales "Valsartan API" contains carcinogen event, CDE has responded! Recently, on the basis of literature research and reaction mechanism analysis, the drug review center (CDE) of the State Food and Drug Administration (SFDA) organized and drafted the "risk warning on the formation of nitrosamines in API process", which is intended to provide technical reference for the risk of the production of nitrosamines in API research and production, and to solicit public opinions from all walks of life See The risk of detection of trace N-nitrosodimethylamine (NDMA) and n-nitrosodiediamine (NDEA) impurities was found in the marketed valsartan APIs According to the list of carcinogens of the International Cancer Research Institute of the World Health Organization, NDMA and NDEA belong to class 2A carcinogens, that is, the substances with limited evidence of carcinogenicity to human beings but sufficient evidence of carcinogenicity to experimental animals At the same time, nitrosamines belong to the substances with high carcinogenicity (focus group) clearly proposed in the guideline of ichm7, which should be strictly controlled in drugs At present, the drug regulatory agencies of the United States and the European Union have successively issued announcements to take risk control measures for different sartans from different suppliers Medicine R & D biology similar medicine fire, Samsung into the Bureau, Qilu, Fuhong Hanlin heavy pounds will be on the market soon! In recent years, with the advent of the patent cliff, many biomedical companies have lost patent protection for their best-selling drugs, including Amgen etamab, ibrevidamumab, Roche rituximab, bevacizumab, etc., and the market of biological similar drugs has become the big cake pursued by major pharmaceutical companies Recently, Sansheng pharmaceutical announced that it has reached a cooperation agreement with Samsung bioepis, which will carry out clinical research and development and commercialization of several bioepis products under research in China, including sb8, a bioepis product under research of bevacizumab The application for bevacizumab's biological similar drugs is also very hot in China Eight domestic enterprises, such as Xinda biology and Dongyao pharmaceutical, are carrying out phase III clinical trials Qilu pharmaceutical has the fastest progress On August 15, 2018, its application for listing was accepted In addition, the listing application of rituximab biological similar drugs declared by Fuhong Hanlin was also undertaken on September 6, 2018 Moreover, both drugs have been included in the priority review and are on the market The second domestic PD-1 antibody, new indication phase III clinical completion of the first case of administration recently, Xinda biological PD-1 monoclonal antibody dabushu ® (xindili mAb injection) combined with capecitabine and oxaliplatin in the first-line treatment of unresectable local advanced, recurrent / metastatic gastric and gastroesophageal junction adenocarcinoma phase III clinical (orient-16) completed the first case of administration The study plans to enroll 650 patients The drug is the second domestic PD-1 antibody drug listed in China It was approved by the State Food and Drug Administration on December 27, 2018 for the treatment of relapsed or refractory classic Hodgkin's lymphoma after at least second-line system chemotherapy Biotherapeutic transferred part of its rights and interests in bevacizumab bioequivalent drugs recently, biotherapeutic and Cipla reached a licensing and commercialization agreement on a bevacizumab bioequivalent drug bat1706 developed by biotherapeutic Bevacizumab has been approved in the world, including metastatic tuberculosis