Generics are already sharpening their knives. How will the cakes in the market be distributed?

Another batch of priority review lists have been released The priority review does reduce the waiting time for approval, which is potentially behind the more intense time to market Originally, the pace of jogging has now become fast running, the market is not waiting for others, and it is more difficult to recover what has fallen This time, we take moxifloxacin, which has entered the priority approval list in 2016, as an example to explore the current market intensity from a single variety Why moxifloxacin? Because it was the largest sales volume on the priority approval list in 2016 Data source? It must be the data in the Ameda national sample public hospital database! Basic information of 01 class moxifloxacin hydrochloride tablets: the acceptance number is cyhs1490056, which was submitted by Beijing Wansheng Pharmaceutical Co., Ltd and publicized on December 2, 2016 The date of undertaking is July 17, 2014 It has been included in the priority review list The current status is: in the review and approval Indications: treat adults with upper and lower respiratory tract infections Such as acute sinusitis, acute attack of chronic bronchitis, community acquired pneumonia, and skin and soft tissue infection Background: in 2008, the European Drug Administration (EMEA) human medical products Committee (CHMP) concluded that the benefit of oral moxifloxacin is still greater than the risk However, due to safety reasons, mainly considering the increase of adverse events of liver damage, CHMP recommends limiting the use of the product For acute bacterial sinusitis and chronic bronchitis, moxifloxacin can only be used when other antibiotics cannot be used or treatment is ineffective; for community-acquired pneumonia, moxifloxacin can only be given when other antibiotics cannot be used Class 02 copy application editor of potential competition simply made statistics on CDE application data of xiamoxifloxacin Under the condition that "application type" is "copy", during the period from 2014 to May 15, 2017, 69 enterprises and 88 acceptance numbers were involved The impact of drug approval reform will not be discussed in detail Although the acceptance number has declined significantly, potential competitors are still eager to try In the national sample public hospital database of Ameda, the general name moxifloxacin had a total sales volume of 1.4 billion yuan in 2016, accounting for 4.6% of the total amount of systemic antibiotics 03 class generic drug listing - impact on the original research drug; the most influential is the original research drug The original manufacturer of moxifloxacin hydrochloride is Bayer company of Germany At present, there are tablets and injections imported from China According to the national sample public hospital database of aimec, Bayer's Bayer occupies nearly 70% of the market share, and two other generic pharmaceutical enterprises, Nanjing Youke pharmaceutical and Chengdu Tiantaishan pharmaceutical, have 25.64% and 4.88% of the market share respectively Moxifloxacin of Nanjing Youke pharmaceutical was approved in 2013, and Chengdu Tiantaishan pharmaceutical was approved in December 2014, all of which were injection In 2016, the total purchase amount of moxifloxacin, the general name of national sample public hospitals (unit: 100 million yuan), entered the priority review of moxifloxacin hydrochloride tablets At present, there is no tablet generic drug on the market In the sample database, Bayer's share of moxifloxacin tablets and injections was 22% and 78%, respectively That is to say, injection is still the main mode of use in the market In terms of price, referring to the listed injection, taking the bidding information of Shanghai in 2016 as an example, the bidding price of baifule is 274.75 yuan, that of moxifloxacin hydrochloride injection of Nanjing Youke pharmaceutical is 233.57 yuan, that of Chengdu Tiantaishan is 229.13 yuan, and the unit price of generic drug is about 16% lower than the original research At present, moxifloxacin injection and oral regular release dosage form are all class B medical insurance products According to the medical insurance catalog, moxifloxacin injection is limited to acute sinusitis, lower respiratory tract infection, community-acquired pneumonia and complex abdominal infection that are not effective with other antibiotics In other words, moxifloxacin can only be used when other drugs are useless Under such conditions, the sales volume of the drug can still reach 1.4 billion yuan, and the future is unlimited.. Because the generic tablet has not yet been put on the market, in terms of price, take a look at the original research The bid winning price of baifule oral tablet in Shanghai is 75.66 yuan, the specification is 0.4g * 3, one tablet a day, the medication cycle is from five to fourteen days, and the dosage form has also entered the national class B Medical Insurance catalogue However, even if reimbursement is available, the burden on patients during the period of oral tablet administration is not light For moxifloxacin hydrochloride tablets to be listed in the future, it will occupy 22% of the market share of the original tablets Class 04 showed in the sample database that the generic name moxifloxacin was the top 1 of the total amount of quinolones, which was the fourth generation of quinolones; in addition, pazufloxacin, Antofloxacin, jimifloxacin and balofloxacin were also the fourth generation of quinolones Moxifloxacin accounted for more than 50% of the market share of quinolones with three manufacturers On the contrary, levofloxacin accounted for 45% of the market share of 113 manufacturers, and the intensity of competition can be imagined; other quinolones fought in the more intense red sea, including some of the fourth generation of better drugs Antofloxacin is the first new fluoroquinolone drug independently developed in China It was listed in 2009, and by 2016, the sales volume of sample hospitals was more than 16 million yuan It can be said that the expected report card of Antofloxacin is not as good as predicted Jimifloxacin and balofloxacin are even worse, among which jimifloxacin is still a B-type medical insurance At present, moxifloxacin is mainly based on injection, and oral generic drugs are still in the pipeline If moxifloxacin hydrochloride tablets can be listed earlier in this priority review, it may have a huge impact on the market pattern of oral quinolones At present, some quinolones have been listed in foreign countries, but not in China, such as finaflocin and besifloxacin (eye drops) approved by FDA, ozenoxacin, Prulifloxacin and sitafloxacin approved by Japan PMDA, ozenoxacin, Prulifloxacin and sitafloxacin Hydrate, garenoxacinmesilate hydrate Among them, cetifloxacin and garefloxacin have been declared by domestic enterprises (besifloxacin (eye drops) has also been declared, which will not be considered here), involving 29 and 1 enterprises respectively Sitafloxacin and garefloxacin are the fourth generation quinolones It is assumed that sitafloxacin and garefloxacin have significant clinical efficacy advantages over moxifloxacin, but price, bidding, medical insurance and other factors are still the threshold of market access Even if all these have passed smoothly, is the drug approved by the clinic and patients? Is patient development smooth? In a very mature market, these are not so easy If there is no significant difference in clinical efficacy, it is more difficult to seize market share Whether quinolones, which have not been listed in China, have obvious clinical value advantages over moxifloxacin can not be determined However, on the premise of the gradual increase of the number of generic drugs of moxifloxacin, it is not easy to get a share For antibiotic drugs, there are two sides: it is not a sunrise direction in itself, especially in the increasingly strict conditions of anti drug restriction, which makes many enterprises survive in the cracks; on the other hand, with the pressure of drug resistance, the common drugs can not play a role, and the drugs that can treat "super bacteria" can fight out in the chaotic Red Sea That is to say, enterprises with antibiotics as the main focus will be submerged in many antibiotics unless they can develop drugs with significant clinical efficacy advantages Now, when the generic drugs are gradually put on the market, the market they seize is not only the share of the original research, but also the occupation of the same kind of competitive products, or even the new drugs to be put on the market, which is different from the early low matching version of the generic drugs With the implementation of consistency evaluation, review and approval reform and other supporting policies of generic drugs, generic drugs will gradually move to a level that can compete with the original drugs The coming of that day will be a rearrangement of the pharmaceutical market Source: Ameda industry research