How long can Zilu, Zinda and other bio-similar drugs enjoy "rich" pricing? This enterprise quietly launched a price war! Will the collection set off the fire?

In fact, the pricing of bio-similar drugs in our country can not be said to be rich, after all, the original research after medical insurance negotiations or even renewal negotiations, artificially pushed down the patent cliff after the price has not been high, leaving space for bio-similar drugs, is not much.
If you look at the high prices and generous pricing space of the original research at the time of the project, it has become an outdated fantasy in the last three years of health-care fee reform, especially with the threat of the subsequent collection.
's most typical Adamo single resistance, where prices rose 18-fold between 2009 and 2019, has been subpoenaed by the U.S. government, while in China, prices remained static in 2017, with health-care negotiations in 2019 and near-immediate biosypoles pushing it down prices twice a year, cutting its price by 85 percent.
, however, there are still some similar drugs priced at about 10% of the original study, which before the collection, is still a "rich" pricing.
At present, China has a total of 4 biopharmaceuticals (single resistance class) of similar drugs approved and listed for sale, involving at least 5 enterprises of 9 products, of which Adamu single anti-competitive, plus a total of 5 enterprises in the original research competition, and Fuhong Hanyu and Xinda Bio is the largest bio-similar drugs, the two biopharmaceutical enterprises only set up about 10 years each approved three products.
in the next 2-3 years, Baiotai, Haizheng, Zhengda Tianqing, Qilu Pharmaceuticals and other enterprises are also expected to have several products approved, roughly expected that by 2022 the domestic biosimilar drugs will reach more than 30.
And the price is a key factor in the development of the biosynthic drug market, before the collection, different products of various enterprises have played a different strategy, E drug managers have been approved for sale of several similar drug prices, from which we can see the pricing strategies of the divisions.
Adamu single resistance: 10% discount price tacit understanding, a penny is not bad today still linked to the global "drug king" of the Shumeile (Adamu single resistance) in the Chinese market sales are not high, and its position in the global market is far from, but this does not prevent it from becoming the most competitive, with the largest number of followers of biological drugs.
At the end of 2019, Biosynaic Drugs of Baiotai and Haizheng Pharmaceuticals were approved one after another, Xinda Bio's products were approved in September 2020, and Fuhong Hanxuan's approval in December 2020, the "stacking effect" has been shown, of which Xinda Biosody is the fastest and has been approved for 6 adaptation certificates.
in terms of price, Fuhong Hanxuan was approved less than a month, the price has not been disclosed, but the other three biosypolycic drugs are not the same price of 1150 yuan / branch.
And the original study meile prices in China has just experienced a cliff-edge decline, after being approved in 2010, has maintained a price of more than 7500 yuan, in 2019 Shumeile has taken the initiative to reduce the price from 7586 yuan / branch to 3160 yuan / branch, that year's health care negotiations, XiuMeiLe price on the basis of the previous price adjustment fell 59.18 percent to 1290 yuan / branch.
Three similar drugs prescribed the same price is about 90% of the original study, such a "discount" is really not low, compared to the international bio-similar drugs 70% discount pricing, Adamo single-resistant bio-similar drugs are generally set a rich "high price", but this high price is only relatively speaking, in overseas markets, because the price of Shumeile is not as "cheap" as the domestic, bio-similar drugs pricing space is relatively large.
but the 10% discount pricing, after the medicare reimbursement difference of only about 50 yuan (in terms of reimbursement 70%, such a difference, whether patients will choose similar drugs is a question.
But its own home market is not excellent, so the future in the biological similar drugs in the clinical market can replace the original research drugs, mainly look at three points, one is health insurance payment, two is hospital coverage, three is the doctor's prescription.
Recently, Xinda Bio's drug-giving policy was first made public, and Thyda Bio will provide 12,000 Sulixin (Adamo mono-anti-biosygenic drugs) for the aid program, with low-income patients able to receive 4-for-2 drug-giving assistance and low-insured patients free of charge for 6 Sulixins.
at the same price, companies are starting to move stupidly and compete for the market.
Beval Bead Single Resistance: 20% of China's similar drugs have been out to sea Beval Pearl Single Resistance currently has two biosimilar drugs approved, respectively, from Zinda Bio and Qilu Pharmaceuticals.
Pharmaceuticals won the first copy of the beva bead monoantigen in 2019 and will enter the national health insurance list in 2019 with the original drug.
Sinda Bio's Dayo is the second approved listed domestic bevazhu single anti-biosynthic drug, first approved in June 2020, has been used for advanced non-small cell lung cancer, metastatic colorectal cancer and adult relapsed glioblastoma 3 adaptation certificate, rapid action.
same time, Hengrui Pharmaceuticals, Green Leaf Pharmaceuticals united Boan Bio, Bayda Pharmaceuticals United Haizheng Bio, Baiotai, Sansheng Pharmaceuticals in 2020 has also submitted applications for the listing of new drugs.
In addition, there are Dongyi Pharmaceuticals, Hualan Biologicals, Fuhong Hanxuan, Shenzhou Cells, Corning Jerry, Huahai Pharmaceuticals, Therese Pharmaceuticals, Zhengda Tianqing and many other enterprises in the layout.
Beva bead monoantigen, developed by Roche, is a recombinant humanized anti-vascular enditer growth factor (VEGF) monoantigen, a commodity called avatin.
since it was approved by the FDA in February 2004 to treat metastatic colorectal cancer, it has been extended to 8 solid tumor adaptation certificates, such as non-small cell lung cancer and glioblastoma.
2010, Roche Beval Beval Bead Single Resistance was approved in China, and before it was included in the health insurance, the winning bid price was 5253 yuan/bottle.
after negotiations to enter the National Health Insurance Directory, it fell to 1998 yuan per bottle in 2017, further to 1934 yuan per bottle in 2018 and again in 2019, GBI data show that its current lowest winning bid is 1500 yuan per bottle.
Qilu Pharmaceutical's pricing in a year from 1266 yuan / bottle to 1198 yuan / bottle, and Zinda's pricing strategy and Adamo single resistance similar, with almost no difference between the competition, set at 1188 yuan / bottle, slightly lower than Qilu Pharmaceutical.
is priced at around 79% compared to Roche's lowest price of 1500 yuan per bottle.
But it's worth noting that Baiotai, which followed up quickly on beval-beaded mono-similar drugs, has also submitted listing applications to China's NMPA, the U.S. FDA and the European EMA, and the sea appears to have become a collective agreement for some of China's powerful bio-similar drug companies.
In addition, Fuhong Hanxuan's Quto Zhudan resistance in 2020 has been approved by the European Union and China's State Drug Administration to list, becoming the first china-EU dual-batch domestic single anti-biosychic drugs, opening the global journey of China's biosychic drugs, Accord Healthcare also obtained the product in the United States, Canada, CIS and other markets exclusive commercial rights.
, which also has global ambitions, authorized commercial interests in the U.S. and Canada for beval-beaded monobial-like drugs to Coherus BioSciences in January 2020, and Coherus plans to file a bio-product license application with the FDA from late 2020 to early 2021.
With the expiration of some of the original "explosive" patents in the U.S. market, the potential of similar drugs in the U.S. market in the next 1-2 years has greatly increased, becoming a new "golden field", entering the U.S. market is undoubtedly one of the ways for global biosygenic pharmaceutical companies to open up territory.
IQVIA believes that biopharmaceutical companies, mainly Indo-Chinese pharmaceutical companies, will look for opportunities to bring their biologics up to export standards, and that the cost of opening up markets and doing business, mainly through access partnerships, will be much lower than that of Western and large multinationals.
these companies' products are not attractive to everyone, they have the opportunity to enter the market with little competitive pressure and get a higher premium."
Litoxi single resistance: 4.5 percent price war quietly sounded from here Lytosi single resistance of the original research for Roche's well-known Melohua, Merrowa in July 2017 health care negotiations successfully entered the national health care directory, 50 The size of 0mg/50ml/bottle was reduced from 16041 yuan to 8298 yuan, while the price of small size 100mg/10ml/bottle was reduced to 2418 yuan, a drop of 58.45%.
, which was approved in February 2019 by Fuhong Hanxuan, is China's first biosimilar drug, modelled on Merohua.
Fuhong Hanxuan's latest winning bid price shows that after more than a year of commercialization, its price has also declined, from 1640 yuan / bottle to the current minimum price of 1398 yuan / bottle, while Roche's current lowest bid price is 2294 yuan / bottle.
Sinda Bio's Lytoxi single anti-biosygenic drug developed jointly with Lilly, approved less than three months, according to GBI data, Cynda Bio is currently in Zhejiang, Guangxi and other three places, but no public price, while Lilly in Shaanxi and Jiangxi bid, in Shaanxi's latest winning information, but revealed the price of Cynda Bio: 1030 yuan / bottle.
the price appears to have broken the "price tacit understanding" between biosypotonic drugs and opened the gap with the competition.
it can be said that lyxi monoantigen is currently the lowest price of domestic bio-similar drugs, Fuhong Hanxuan pricing for the original study of 60% off, while Xinda is as low as 45%.
, according to the latest IQVIA CHPA data, in 2019, lyxi monoantigen injections in China sales of about 2.505 billion yuan.
' sales in China are about 150 million yuan, according to data released by Fosun Pharma, meaning that the drug still dominates the vast majority of the market.
But under the price gap with the original research, the release of similar drugs is very obvious, Fu hong Hanxuan has said that previously limited by the approval of the market when the use of 500L production equipment led to relatively limited production capacity, the pace of release is limited, in 2020 approved to increase production, will increase the production capacity of the drug, to ensure a sustainable and stable market supply.
among them, due to the approval of new production capacity, capacity constraints resolved, Hanlikang in June 2020 sales rapidly released, to Fosun Pharma sales caliber statistics, June sales alone exceeded 100 million yuan.
the rapid release of competing products, the strategy of Ingda Bio, which was approved at the end of 2020 to break the "price tacit understanding", is also understandable.
bead single resistance: when will the price storm come under the price quite a set? The curtoju monoantigen drug Hersatin, developed by Roche, is a humanized monoclonal antibody derived from recombinant DNA derived from human skin growth factor 2 (Her2).
since its approval in 1998,
has been on the top list of the world's best-selling drugs for many years, with global sales of $7.1 billion in 2017, but after the peak the patent expired and sales declined as a result of biosynthic drugs.
But in the domestic market, the original research Hessetin 2017 health care price of 7600 yuan /bottle (440mg), in 2019 by the National Health Insurance Administration renegotiable, the original research again reduced the price to complete the renewal of health insurance, the current unit price of about 5,500 yuan / bottle (440mg).
market continues to release volume, according to IQVIA CHAPTM statistics, in 2018 and 2019 Quto Zhuzhu single resistance sales in China amounted to about 2.73 billion yuan and 4.57 billion yuan, respectively, showing an upward trend year by year.
-like drug (Hanquyou) is currently priced at 1688 yuan/bottle (150mg), and in some areas has been reduced to 1543/bottle (150mg).
To the auxiliary treatment of breast cancer, for example, after the completion of all chemotherapy can start the treatment of curvature pearl single resistance, a weight of about 50 to 60 kg patients, if the cost of using the original research treatment for a year in about 80,000 (before medical insurance reimbursement), and if the use of Han Quyou then this cost is also about 80,000 yuan (before medical insurance reimbursement), the price is not much different from the original research.
In response to the impact of Hercetin biosynamics, Roche has introduced Perjeta (Pato Pearl Monoanti) and Kadcyla (Enmetro-Bead Monoanti) in succession, in which Perjeta, although the same as the curly bead mono-resistance target, but the two are different from HER2 binding points, the combined use can play a synergy to prevent the growth and survival of cancer cells.
, Kadcyla is an antibody-coupled drug with 2 anti-cancer properties, her2 inhibitory effects of curvature monoantigen and cytotoxicity of DM1.
so far, Perjeta and Kadcyla have been approved for listing in China.
the current winning bid of 19282 yuan (100mg/bottle), a huge difference from the Hessetine price.
the four best-selling biologic drugs, global sales totaled $38.76 billion in 2019, down 4.3 percent over the same period, but domestic sales totaled about $10 billion, but are growing.
but whether biosynthics or primary drugs, in the short-term visible days are facing the risk of collection.
The State Administration of Health Insurance, in its reply to Recommendation No. 6450 of the Third Session of the 13th National People's Congress, made it clear that, on the basis of taking into account factors such as the similarity of biosynthic drugs, the stability of enterprise capacity and supply chain, and the clinical substitution of specific products, centralized volume procurement should be carried out in due course;
industry insiders say that whether from the health care policy or centralized procurement, clinical drug guidelines, for biosygenic drugs in the clinical replacement of the original drug to provide a basis.
With the approval of China's bio-similar drugs products, explosive products less have four or five enterprises to declare, more than 20 enterprises pile up competition, bio-similar drugs price war is not far away.
The opening year of 2021, the fourth batch of national mining has been in the early stages of operation, and the current market has three products of biological drugs (single resistance class) has reached three, the second half of this year's fifth batch of collection will be included in bio-similar drugs, it is worth looking forward to.
but Fuhong Hanxuan CEO Zhang Wenjie also expressed a different view, he believes that at present, bio-similar drugs into the feasibility of harvesting is not enough, and premature collection may not be conducive to the industry