Will the priority approval of generic drugs make the market tremble?

Since 2016, CFDA has started the priority review and approval Now, more than one year after the priority review, the first batch of priority review drugs have already been approved Half of 2017 is about to be completed, and 16 batches of priority review publicity list have been published We will analyze the 13th batch of generic drugs that obtained the priority review qualification in 2017 to see how the impact on the future market of these drugs once they are listed Metformin metformin can be said to be an old driver in the field of diabetes treatment This time, the European pharmaceutical industry of Petrochemicals Group can also obtain the qualification of priority evaluation, which really opened the eyes of the insiders The reason given by the State Food and drug administration is that "the same production line has been listed in the United States, and the generic drugs applied for listing in China" However, metformin of lithopone was listed in the United States as early as 2013, and now it has entered the priority review list in 2017 That is to say, the drugs used by American patients have not been used by Chinese patients This time span is somewhat puzzling Perhaps, Sinopharm group just saw the helplessness before the reform of domestic drug review, and transferred to the international market, but now it has ushered in a stronger competitiveness Continue to dig deep, as early as 2002, the metformin API of petrochemicals has been listed in China, and the domestic market competition is very fierce According to the national sample public hospital database of Ameda, in 2016, the sales volume of metformin was nearly 500 million yuan, among which 43 enterprises produced metformin In addition to the original research manufacturer Shiguibao accounting for more than 95%, the market share of other enterprises was quite scattered In such a big environment, it's really a thankless job to get a share In this way, the transfer to the international market can transfer competitiveness, which may be a very challenging decision in 2013 It is understood that in 2016, the metformin of Sinopharm group achieved sales of about $5 million in the United States If it wasn't for the 2016 generic consistency review, the story would have been plain On May 26 last year, the General Administration of the people's Republic of China issued a notice on the implementation of the opinions of the general office of the State Council on the evaluation of the quality and efficacy of generic drugs "The acceptance and Reporting Center shall be responsible for the acceptance of the application materials of the drugs produced and listed in the same production line in China and approved to be listed in the EU, the United States or Japan; the consistency evaluation office shall notify the drug review center of the food and drug administration to review the application materials of the original domestic and foreign listing, and notify the food and drug review and inspection center of the food and drug administration to conduct the production On site inspection It shall be deemed to have passed the conformity assessment after being reviewed and approved by the conformity assessment office " In addition, "if there are more than three manufacturers that have passed the consistency evaluation of the same kind of drugs, no more varieties that have failed the consistency evaluation will be selected in the centralized purchase of drugs." For metformin, which is to win at the starting line, and it's almost to the end, OK!? At a time when most enterprises are still struggling for the consistency evaluation of generic drugs, petrochemicals have been killed back to China through overseas varieties, which is equivalent to passing the consistency evaluation In the future bidding process, petrochemicals will be directly favored by the policy There are two vacancies in the three places, and more than 40 enterprises are competing for the two vacancies However, in the list of four batches of official reference preparations released by CFDA, there is no original research information of metformin, and the enterprises can only be ants on the hot pot After metformin of petrochemicals goes on the market, it will have a huge impact on the scattered generic pharmaceutical enterprises In the market of nearly 500 million yuan, there will be few qualified to pursue Paclitaxel (albumin binding type) is also a generic drug product of the European pharmaceutical industry of Petrochemicals Group The reasons for inclusion in the priority review are: clinical urgent need, market shortage and first imitation However, in the last year, Hengrui's listing application for paclitaxel (albumin binding type) was included in the priority review, and the approval document has been issued after the completion of the certification This time, the listing application of paclitaxel (albumin binding type) from euryi Pharmaceutical Co., Ltd of Sinopharm group was included in the priority review list It can be seen that it is really a clinical urgent need and market shortage According to the national sample public hospital database of Ameda, the total sales of taxol is about 700 million yuan, and only one Taxol (albumin binding type) has sales, which is the new base Biology (original research) in the United States, with sales of more than 200 million yuan Guys, this is only the national sample data! Taxanes are important new drugs approved for clinical treatment of tumor, mainly used in the treatment of metastatic breast cancer, ovarian cancer and non-small cell lung cancer However, the solvent-based paclitaxel on the market still has serious side effects and allergic reactions related to solvent, even though it is used properly before operation Albumin binding paclitaxel is a new type of solventless paclitaxel It does not need synthetic solvent as carrier, does not need pretreatment such as corticosteroids or antihistamines, and the intravenous infusion time is short (30 minutes) It uses the natural biological characteristics of albumin to increase the uptake and accumulation of paclitaxel in tumor tissue through the interaction of gp-60 (glycosylated capsule protein) mediated transmembrane transport of endothelial cells and SPARC (an acidic cysteine rich secretory protein), a protein binding with albumin The preclinical model study confirmed that the antitumor activity of albumin binding paclitaxel was significantly higher than that of solvent paclitaxel That is to say, albumin binding paclitaxel is an upgraded version of paclitaxel! At present, the median national bidding price of new paclitaxel (albumin binding type) is about 5820 yuan / 100mg, while the national bidding price of Paclitaxel injection (quality level: drug with "national key new product" certificate issued by the Ministry of science and Technology) is about 360 yuan, 10ml: 60mg There is no generic drug of paclitaxel (albumin binding type) on the market, so only the original manufacturer of new base organisms has been sold in the market, and the burden of drug use for patients is very large Now, Hengrui has been approved to go on the market, and the stone medicine company is on its way There are not many days for the original research manufacturer to earn money The reason why bensulfosan atracurium injection is included in the priority approval is that the generic drugs produced in the same production line, which have been listed in the United States and applied for domestic listing, are applied for by Jiangsu Hengrui This product is used for operation and other operations as well as intensive care treatment As an auxiliary drug of general anesthesia or as a sedative in intensive care unit (ICU), it can relax skeletal muscle and make tracheal intubation and mechanical ventilation easy In the national sample public hospital database of aimec, there are four pharmaceutical companies with sales data in the current market, namely Jiangsu Hengrui, Shanghai pharmaceutical, Zhejiang Xianju and GlaxoSmithKline, among which GlaxoSmithKline is the original manufacturer, and the market share is shown in the table below: It can be seen that at present, shunatracurium of Jiangsu Hengrui has occupied more than 65% of the market share, while GlaxoSmithKline, the original manufacturer, has lost less than 1% of the market share When the original research was withdrawn from the market, the rest was the competition of domestic generic drugs In terms of generic drug applications, in addition to bensulfosan atracurium injection of Jiangsu Hengrui, there are 16 generic drug application listing numbers, involving 10 pharmaceutical enterprises, and all of them are in the review stage This time, shunatracurium of Jiangsu Hengrui obtained the priority approval qualification, and it was based on the reason that "the same production line has been listed in the United States", which is similar to metformin of Shiyao group, leaving little time for other generic pharmaceutical enterprises According to the application for listing of generic drugs for Huahai Pharmaceutical Co., Ltd filed by yifeiwelun, the original manufacturer, mosadong, was included in the priority review for the treatment of AIDS drugs for the reasons of clinical urgent need and market shortage As early as 2013, Huahai pharmaceutical signed the master agreement on contract processing with MSD For MSD, Huahai pharmaceutical produces eferene tablets in the global market including the domestic market, and MSD is responsible for the sales, which is equivalent to that Huahai works as a pharmaceutical agent for MSD, and there is a big gap in profit compared with the original research drug Prior to this, Huahai pharmaceutical declared that all the new drugs were imported in the name of iflaviron The priority review of iflaviron was listed in the name of generic drugs Once the listing is successful, the impact of generic drugs on the original research drugs will be huge At present, as a pharmaceutical manufacturer, Huahai can't compare its profits with the original research, but if it produces generic drugs for itself, it will be another time According to the full sample public hospital database of Ameda, the sales volume of efaviron in 2014 was only about 24000 yuan, and increased to about 730000 yuan in 2016, with a compound growth rate of 450% in recent years! According to the editor, efaviron as a drug for AIDS, there is its particularity, the drug can be used as a free drug in a specific population At the end of 2016, Shanghai desino biomedical Co., Ltd obtained the approval number of generic drugs of efaviron tablets For Huahai pharmaceutical industry, although the original research drug is produced by itself, there are still many generic pharmaceutical enterprises in the market, and the market competition is still fierce The reason for dantraline sodium to be included in the list is: it is used for rare diseases, and the indication is the spasmodic muscle tension increase state left by upper motor neuron injury caused by various reasons, such as stroke, brain injury, spinal cord injury, cerebral palsy, multiple cerebral vascular sclerosis, etc., which is declared by Zhuhai Lizhu Synthetic Pharmaceutical Co., Ltd in tax protection area In the State Food and drug administration, only danqulin sodium capsule produced by Hunan Dino Pharmaceutical Co., Ltd can be found Curiously, Xiaobian did not find the sales data of dantraline sodium in the national sample public hospital database of Ameda, nor the sales data and bid winning information of the drug in the mainstream drug data query database It's puzzling that this time it was included in the priority examination and approval Can you give me some advice if you understand the details? Thank you very much Reasons for latanoprost eye drops (latanoprost / timolol) to be included in the list: first imitation, submitted by Qilu pharmaceutical, the original manufacturer is Pfizer Indications: to reduce the elevated intraocular pressure in patients with open-angle glaucoma and ocular hypertension At present, it is still under review and approval In the national sample public hospital database of Ameda, the sales data of latantimer eye drops in 2016 was nearly 6 million yuan, with a compound growth rate of 27%, and the median national bidding price was about 200 yuan At present, it seems that no other domestic enterprises have applied for latantemio eye drops Finally, what Xiaobian wants to say is that priority approval creates a precedent for approval efficiency, enabling excellent and short drugs to quickly complete the approval process, enter clinical or market, and greatly save the waiting time for approval, which is definitely a good policy Moreover, most of the applications that can enter the priority approval list are also high-quality generic drugs, once listed, the impact on this field will be huge.