The Price Of The Original Research Medicine Is Reduced To Medical Care, And The Development And Commercialization Of The Soil Biological Analogues Will Embark On A New Journey.

In March 23rd, Fuhong pharmaceutical company Fu Hung Han Lin released the 2019 annual report, the first domestic biological similar medicine drying out the first year report card.

In 2019, the revenue of Fu Hong Lin was about 90 million 900 thousand yuan, and its main contribution came from commercialization of rituximab (trade name: Han Li Kang). The total annual loss was 875 million yuan, mainly due to the expansion of R & D.

Since the first biosimilar drug rituximab was launched in early 2019, four biopharmaceuticals have been listed in China. They are listed as bioactive monoclonal antibody (adalimumab), An Jianning, and bevacizumab.

Although the development of rituximab biological analogues is "ten years' sword", it is far from the current small molecule drugs in catching up with international speed. Liu Shigao, co-founder, President and chief executive officer of Fu Hung Han Lin, said at Han's marketing conference, "Han Li Kang is the world's third approved biosimilar drug rituximab."

Following the United States and Europe, the Chinese market has become the most popular research and development pipeline for biosimilar drugs, similar to the layout of PD-1/L1 drugs. Fierce competition is inevitable. Domestic enterprises face many challenges and opportunities in R & D, variety selection, card listing and subsequent commercial sales, channels, capacity and price.

Competition with original research

Biological analogues refer to therapeutic biological products that are similar in quality, safety and efficacy to those already approved. A large number of biopharmaceuticals will help to increase the accessibility of biological drugs and lower prices, so that more patients can use drugs.

Unlike the imitation of small molecule chemicals, the development of biological analogues is much more complicated. Because of the characteristics of the manufacturing process and the molecule itself, it is very difficult for the biological macromolecule drugs to be the same as the structure and function of the original drug.

According to the data given by Liu Shigao, an original research biological medicine takes about 8~10 years and 800 million dollars to succeed. Biological analogues need more steps to spend about 7~8 years and 1~3 billion dollars.

Europe and the United States began to develop and invest in biological analogues many years ago, and also met the demand of control fees in various countries. Regulators also gave positive feedback. Transnational pharmaceutical companies are also common in disputes over patent cliff and bio analogues.

In February 2017, South Korea's Celltrion Truxima was first approved by the European Union. In June 2017, Sanders's Rixathon was approved in the European Union. In November 2018, Truxima was also approved by the FDA.

According to the new drug approval report issued by the FDA drug assessment and Research Center (CDER) in 2019, CDER approved ten new biosimilars. "This will further help create competition, increase patient utilization and reduce the cost of important biopharmaceutical therapies."

At the same time, the original pharmaceutical companies adopted a more direct way of competition. Since 2017, many popular McAb drugs have entered the health insurance directory through a substantial price cut.

Rituximab, the original research drug, is Roche's rituximab. It is the first monoclonal antibody designed for the treatment of cancer by the Roche gene, FDA. Currently, rituximab already has biosimilar drugs in Europe and the United States. In April 21, 2000, Roche rituximab was approved by CFDA and entered the health insurance directory through negotiation in 2017. The price dropped by 58.45%. Thereafter, the market was clear. The size of the 500mg/50ml/ bottle is reduced from 16041 yuan to 8298 yuan, and the 100mg/10ml/ bottle size is reduced to 2418 yuan.

In November 2019, the national health insurance negotiations were settled, and seven years after the reelection of Miller (adalimumab), the global "medicine king" has entered the medical insurance for many years. Xiu Mei Lecong single price more than 7600 yuan, to the net to take the initiative to price 60% to 3160 yuan, until the 1290 yuan / branch won the national health insurance directory.

Under such circumstances, enterprises with biological analogues have to adjust their strategies to compete with the original ones at lower prices.

"Because the industry as a whole still has a large upward space, home-made analogues have a replacement process for original research, or some market space can be grabbed." "In the case of a price drop of up to 60-70%, the value and income of similar pharmaceutical companies may not be as high as previously expected, and it is also not consistent with the financial model of the establishment period," said Gao Rong, executive director of Oriental high Sheng, to the twenty-first Century economic report.

After the listing, Han Li Kang further lowered the price. The price at the time of listing was 1648 yuan /10ml:0.1g, which was lower than about 30% of the original Roche drugs with the same quality regulations. After further price reduction, the price of the retail drugstore in the whole country was 1398 yuan / Branch (100mg / 10ml).

"The listing of Han Li Kang has opened the era of China's new antibody drug. Market feedback, the product is currently in short supply, constrained by capacity, at present, enterprises are already expanding their efforts. " An industry insider told reporters, "the product is currently applying for new indications, and in the United States, the European Union and other listed applications will become the first bio similar product to produce global sales in China, and the market potential is worth looking at."

Competition with peers

In addition to the "price war" with the original research, domestic bio analogues manufacturers are also facing fierce competition with many similar products.

IQVIA AI predicted that with the expiration of the patent of biological medicine and the listing of a large number of biopharmaceutical drugs, the global bio similar drugs will reach the market scale of about US $30 billion in 2020. The market share of China's biopharmaceutical and biological analogues accounts for about 1% of the world's total. The number of research projects in the world ranks first in the world, and is concentrated in the field of cancer and immune diseases. It is estimated that by 2030, the sales of Chinese antibody analogues will reach US $4 billion 200 million, accounting for 35% of the total sales of these drugs.

On the main McAb drugs, rituximab, trastuzumab, bevacizumab, adalimumab, infliximab, etanercept and other drugs, including Fu Hong Lin, XinDa biology, Corelle Jerry, Shenzhou cell, Hai Zheng pharmaceutical, Qilu pharmaceutical, Lizhu pharmaceutical, Zhengda Tian Qing, Sansheng Guo Jian, Shuang Lu pharmaceutical, Hua Lan gene and so on, a large number of enterprises have entered the field. 。

The industry insiders said, "biological medicine is the fastest growing drug type in the world, and the potential of bio similar drugs is also widely valued. Many enterprises around the world are making efforts to similar biological drugs. The market opportunities are very clear, but the inevitable challenges are simultaneous. On the whole, the market performance of homemade biological analogues is very important to product quality and efficacy, the first advantage of product development and sales, whether the product indications are the same as the original research drugs, whether the products of the enterprises can form a combination, and the ability of market development.

Take Fu Hong Han Lin as an example, in addition to the Han Lian Kang trastuzumab China Europe double newspaper, it became the first biosimilar drug to be accepted by the European Union. HLX02 and HLX03 (Adalimumab Solution for Injection) were accepted by the SFDA's new drug certificate application and included in the priority review process; the 3 phase clinical trial of HLX04 (bevacizumab biological analogues) has been completed.

From the experience of European and American markets, the first biological advantage of similar drugs is obvious. According to IMS data, the bioequivalent of the first listed biotech market in the European market is very fast, and the share of all biosimilar drugs market is relatively high after the stabilization (averaging 70%). The competition is smaller, and the price decline is obvious compared with the original research drug, which is the main reason to help the first listed bio similar drug to seize the market quickly.

The biological analogues after entry are slightly less competitive in the market. For example, when the second biological analogues Flixabi (Infliximab, infliximab) approved by EMA were approved to enter the European market, after competing with the original research and the first biological analogous drug Renflexis (listed for more than two years), only 0.7% of the market share was grabbed in the first year, and second years of sales growth, and the share of the market increased to 3.4%, and the Remicade was the first one to compete in the European market. Less than Renflexis listed second years of market share of 1/3.

"The trend now is to slowly incorporate monoclonal antibodies into the health care directory to benefit more patients. Therefore, from the market card position, the first advantage is Fu Hong Han, Bo Tai, Qilu and so on. In the gradual approval process of biological similar drugs, the head enterprises will gradually form barriers to channels and sales teams. Innovative pharmaceutical companies have gradually shifted from research and development to commercialization. Qu Rong said that many companies that are still in the early stage of the clinic may stop projects, "because if there are four or five listed companies in the early stage, the price war is bound to happen, and later enterprises will have to build their own business teams at a very high cost, and the cost of digging is also very high. In the future, it will become more and more mature like the American market. Small innovative companies will focus on R & D, and then sell them to big companies for sale.

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