Metformin "disappeared" in the national collection catalogue: 5 billion market is pending

December 29, 2019, in time for the end of the year, the second round of national collection of varieties officially releasedCompared with the previous online circulation of hospital reported 35 varieties, the official list of only 33 varieties, of which "disappeared" is the large varieties of diabetes drug metformin re-release form and metformin oral normal release formas a legendary drug in the field of diabetes, as well as clinical first-line sugar-lowering drugs, metformin corresponds to a total of more than 5 billion yuan in 2018 the size of a huge market, as well as from domestic and foreign dozens of production enterprises of the same competition, the quality of generic drugs and efficacy consistency evaluation of the fierce fightNot long ago, Hebei for 15 kinds of urban and rural residents high blood pressure, diabetes outpatient drugs for centralized procurement, metformin oral reformer form has been included in the collection range, 4.3 cents per piece of procurement price is also a new price recordAnd from the common sense, the national collection of metformin after the big probability will report a lower price than the provincial collection, the entire market pattern of metformin may be rewrittentherefore from this point of view, this time not in the national collection was "named", for a lot of metformin products related to the production enterprises, it seems to be a "lucky"At the very least, in the face of a set price cut, companies can buy a little more time on the marketHowever, the non-finalist is a real "lucky" or another "tragedy", perhaps not yet to be decided01 metformin "lucky" to escapebefore, the industry has voices that, to a certain extent, metformin may be one of the most in line with the national harvesting standards of one of the varietiesone, the market size of metformin is hugeAccording to data from Minet, the market size of metformin in China's public medical institutions and urban physical pharmacy terminals in 2018 has exceeded 5 billion yuanIn 2018, the market for metformin at the end of public hospitals in key provinces and cities in China was 633 million yuan, an increase of 11.94 percent over the previous yearsecond, through the consistency of the number of manufacturers of generic drugsInsight database information shows that, whether it is the re-release agent form or oral normal release dosage form, metformin has a number of consistent evaluation of the evaluation of enterprises, it can be said that the competitive situation has been very fiercethree, the original research varieties market accounted for a relatively highAt present, the domestic import of metformin metformin slow release tablet products called Gehua, its original research enterprise for Merck Group's biopharmaceutical business branch Merck Sherano company, in 2016 and before Merck will be the Chinese market in China and the United States and Shanghai Shiguibao Pharmaceutical sub-sales, and then with The Squibb divested diabetes business and returned to Merck Previous lying public data show that the original research products in the entire market for metformin accounted for up to 80% in addition, metformin is also the base drug catalog varieties, national health insurance varieties As the clinical preferred first-line sugar-lowering drug, metformin has been included in the national collection range, has been in the industry's general expectations As a result, the disappearance of the two dosimetin sequine in the final catalogue has caused a great deal of concern for the relevant enterprises, temporarily avoid the national harvest of the storm, in fact, but also in the face of a set of sharp price cuts in the short time to fight for a little more time in the market In November 2019, Hebei Province has issued a document for 15 urban and rural residents of hypertension, diabetes outpatient drugs for centralized procurement, which includes metformin oral reprecytosis, the estimated procurement volume of up to 500 million tablets But specific to the selected price, the final winning stone drug Eu-Italian metformin tablets (0.5g) its price is only 0.043 yuan / tablet, than the previous document published the maximum price of 0.102 yuan / tablet is also 57.9% lower, visible price fighting fierce from a common sense, the national harvest of metformin after the large probability will report a lower price than the provincial collection And as the original research products, from the current bidding price around 1 yuan, its substantial price reduction and domestic varieties to compete is not very likely, the use of many years of patient base to seize the off-hospital market may be a more likely strategy And for many production enterprises that have passed the consistency evaluation, want to win in the collection will inevitably usher in a "head-breaking blood flow" killing, to see who can seize more markets 02 unexpected "black swan": some enterprises said they have received the order to stop production
but in the industry have discussed why metformin did not appear in this round of harvest, a more than a day before the news began to arouse everyone's concern, that is, from overseas metformin raw material sino impurities wave may have begun to affect the domestic market December 5, 2019, the U.S FDA announced that it had begun testing the samples of metformin for over-limits of the carcinogen N-nitromedmethamphetamine, the NDMA that had previously attracted widespread attention because of the sastenan incident Industry sources to E drug managers revealed that the first international drug regulatory agencies in Poland in metformin found trace amounts of NDMA and attracted attention, and then the United States also launched an investigation Janet Woodcock, director of the FDA's Center for Drug Assessment and Research, also issued a statement on impurities found in diabetes drugs outside the U.S., saying that "
, based on the information we have, NDMA levels outside the U.S are naturally present in certain foods and waters." While we know that some regulators outside the U.S may recall some metformin drugs, there have been no recalls of metformin affecting the U.S market The FDA is investigating whether metformin in the U.S market contains NDMA and is above the daily acceptable intake limit of 96ng The FDA will also work with companies to test samples of metformin sold in the United States and recommend a recall as appropriate if high levels of NDMA are found in metformin drugs According to the Baidu Encyclopedia, N-nitrometdiamine (NDMA), a chemical produced by the reaction of metformin and nitrite in acidic conditions, is widely present in the environment and has previously been listed as a suspected chemical carcinogen in humans by the Association of Industrial Hygienologists (ACGIH) of the United States Government and apparently, such an overseas inspection has extended its impact to the country industry sources told E drug managers that their enterprises have metformin-related products production, about a month ago has received from the local drug regulatory departments of verbal production instructions In accordance with the requirements of the regulatory authorities, enterprises should suspend the use of the current metformin API raw materials, until the corresponding batch of raw materials after the inspection of the drug regulatory department before production E drug manager obtained another document picture shows that the Henan Provincial Drug Administration also issued on December 24 "on the renitin metformin products to carry out a special inspection notice", a total of 8 special inspection working groups will be between December 25 and 27 to carry out special inspection of the corresponding varieties and enterprises, of which metformin products involving enterprises for 12 and in The Province of Shandong Province, where metformin raw materials enterprises gather, some industry sources said that the regulatory authorities also issued a verbal notice Shandong Shouguang Fukang Pharmaceuticals, Shandong Keyuan Pharmaceuticals, etc are the main producers of metformin apicosin raw materials industry analysis that the reason for the transfer of metformin out of the collection catalog, perhaps to a certain extent also related to this event, which is also out of the product safety and the vast number of patients responsible for the safety of drug safety considerations E drug managers at this time to the official first time to verify, but as of the time has not been returned to the draft but it is important to stress that it is clear from previous incidents of shattan and renitinthat that NDMA, although classified as a suspected chemical carcinogen, is closely related to the dose and is itself a common pollutant found in water and food, including pickled and grilled meats, dairy products and vegetables Everyone is exposed to some level of NDMA In an open letter released by the FDA, it also stressed: "
fda and the international scientific community do not believe that low levels of ingestion are harmful." In the United States, the acceptable daily intake limit for NDMA is 96 ng Genetically toxic substances such as NDMA may increase the risk of cancer if people are exposed to excessive levels over a long period of time, but taking drugs containing NDMA for 70 years under the daily intake limit is not expected to increase the risk of cancer (The FDA and the international scientific community do not do it to cause harmingsing at low levels.) The will daily intake limit for NDMA in the U.S is 96 nanograms Genotoxic substances such as NDMA may the risk of cancer if people are exposed to their s at the level and over long s for time, a person take a drug take-in-takes-contains ndma at-or-at the-place-intake daily intake daily for 70 years is not-ethto have hadan anant in at the same time, the FDA's filing also emphasizes that metformin is a prescription drug used to control high blood sugar in people with type 2 diabetes Patients should continue to take metformin to control diabetes For severe patients, stopping taking metformin without prior communication with a healthcare professional can be dangerous The FDA recommends that prescription physicians continue to use metformin when clinically appropriate, as the FDA investigation is still ongoing and no other drug can treat the condition in the same way (Metforminis a prescription drug used to control high sugar in patients with type type 2diabetes Patients s d d take metformin to theirkeepsunder control It can be dangerous for patients with this serious serious sitto stop take theirs metformin without out first talking to health careprofessional The FDA recommends prescribers sto use metformin whenclinically, as the FDA's anis still ongoing, and thereare no alternative s it tha this thin ness )