Biopharmaceonceons with volume procurement approaching

On 17 February, the first day of the new year, CDE issued the Technical Guidelines for the Evaluation of Biosypolor Drug Similarity and Adaptation Extratrophics, which aims to further standardize and guide the development and evaluation of biosypoloric drugs, as well as pave the way for the procurement of biopharmaceusical bands, in particular by clarifying that "all adaptations of biosypolor drugs cannot be automatically extratrophic reference drugs", "Adaptation extraterrion should be considered individually according to the characteristics of the product and the characteristics of the target adaptation", i.e., to be approved, individual evidence must be submitted for each adaptation.
On January 28 this year, the State Council issued the Opinions on Promoting the Normalization and Institutionalization of the Purchase of Concentrated Drug Volumes, which requires that "the clinically necessary and reliable types of medicines for domestic market should be gradually covered, so that they should be harvested", and the next day (1 At a regular briefing on State Council policy held on September 29, the head of the Health Insurance Bureau further stressed that "there are differences in the quality evaluation methods of generic drugs with biosimilars, but it has strict quality standards, and the next step is unquestionable."
" and when it comes to biopharmaceonces, what are the concerns about biosynthics? What is the status quo in our country? How much does the price difference between Chinese and foreign biological drugs differ? One by one, the analysis is as follows.
, what is biosimilar refers to therapeutic biological products that are similar in quality, safety and ability to approved reference drugs.
Because the structure of chemical drugs is clear, so generic drugs can do and the original drug in the chemical structure and hand, etc. are exactly the same, and biological drug molecular structure is much more complex than chemical drugs, biosimilar drugs can not be completely consistent with the original drug, can only be similar to the original drug (similar), so called biosimilar drugs, such as vaccines, blood and blood components, somatic cells, gene therapy, tissue and recombinant therapeutic proteins.
II. How many biosimilar drugs have been listed in China to mono-resistance as an example, so far, China has approved the listing of Zinda, Fuhong Hanxuan, Qilu, Haizheng and Beijing Baiotai and other five domestic enterprises 9 biosimilar drugs (Figure 1), respectively, imitation of the Roche troika called Merrova, Hessetine and Anvetin, as well as the global drug king for 9 years of Abelville.
From the current price point of view, Fuhong Hanxuan's Hanlikang and the original research drug difference is the largest, the current price of 1398 yuan / branch, less than its original research Mei Luohua 7866 yuan 1/5 (18%), Hanlikang after the listing has also experienced a price reduction, from the original 1640 yuan / branch Down to the current 1398 yuan / bottle, its original research drug Roche's Merrowa after the 2017 national health care negotiations from 16041 yuan / branch to 8298 yuan / branch (500mg / 50ml / bottle), and then down to the current 7866 yuan / branch.
and the smallest difference between the original research drug price is Baiotai's Greli, Haizheng's AnJianning and Xinda's Su Lixin, are currently 1150 yuan / branch, only 11% lower than the original research drug repair meth, And Xiu Meile in order to enter health insurance, in 2019 before the health care negotiations to take the initiative from 7586 yuan / branch to 3160 yuan / branch, after the success of the national talks fell by 59% to the current 1290 yuan / branch.
30 and December 2 last year, respectively, have not yet seen a sale price.
3. The price difference between China and the United States has been reduced by high drug prices for many years, but the first state-led drug price negotiations since 2016, especially the health care negotiations led by the newly established National Health Insurance Administration in 2018 At the beginning, China's drug prices have been significantly reduced, even lower than the international drug prices, greatly reducing the burden on patients, to china has been listed in the eight single resistance for example (Figure 2, according to the U.S. dollar to 6.5 yuan), compared with the U.S. market, The biggest difference is Shumeile, the specification of 40mg / 0.4ml Shumeile in the United States selling price of 40560 yuan / branch, and in our country only sold 1290 yuan / branch, only equivalent to the United States price of 3.3 2%, as the global drug king, is currently also the most imitation of domestic enterprises biogenic research drugs, once included in the national collection, such as the first 5 national harvest average decline of 50%, will be further reduced to about 600 yuan / branch.
The smallest difference between China and the United States is Yang Sen's class (Invlixi single resistance 100mg), the United States price of 7889 yuan / branch, domestic price of 5160 yuan / branch, only 35% cheaper than the United States.
The other smaller difference is the ophthalmology drug Abersip (0.1ml: 4mg), which sells for more than 10,000 yuan (12,617 yuan/branch) in the U.S. and only 5,850 yuan/branch in China, which is more than half as cheap as in the U.S. (53%).
At present, only in Wuhan and other places when the collection of biological drugs, but the national collection has not been involved, with the rapid progress of the belt procurement of full coverage strategy, biological drugs into the national belt procurement is approaching, price decline, generic drug replacement immediately occurred, of which, Roche will be the first foreign enterprises, domestic imitation of the four single resistance of 3 from Roche, these three drugs accounted for 1/5 of Roche's global sales.
With the expiration of patents for heavy biopharmaceons, the speed of the market of biosynthic drugs is also accelerating, more than 700 biosynthic drugs are being studied worldwide, nearly 400 biosynthic drugs are being studied in China (by the end of 2019), and more than 50 biosynthic drugs will be approved for sale in China by next year (2022), although Biopharmaceutical competition is becoming increasingly fierce, but biopharmaceuticals are still The fastest rising sub-sectors in China's pharmaceutical sector, the market potential is huge, according to Huatron Securities forecast, assuming that after the future volume of procurement, the price fell to 5-10% of the price in Europe and the United States, and the penetration rate is 5-10 times, or even higher room for improvement, then these antibody drugs will still be 1-3 billion levels of large varieties.
, in the face of fierce domestic competition at the same time, domestic biopharmace products exported overseas will also bring considerable income to enterprises.