Biopharmaceutical Centralized Purchase Steps Approaching 150 Billion Market Structure Changes

The collection of biopharmaceuticals is approaching.

Recently, in the letter of reply to the proposal No. 3013 (medical and sports 184) of the fourth session of the 13th National Committee of the Chinese people's Political Consultative Conference (CPPCC), the State Medical Insurance Bureau said recently that it would take into account the similarity, stability and substitutability of biological agents, and fully solicit opinions from clinical and pharmaceutical experts and relevant enterprises, Find out the production capacity of enterprises and form rules suitable for the characteristics of biological agents.

On the evening of July 28, the State Medical Insurance Bureau issued a document saying that the National Health Insurance Bureau hosted a forum on centralized insulin procurement. A few days ago, a letter on opinions on the centralized procurement scheme of insulin by the state organization (Draft for comments) was circulated in the industry. The draft pointed out that the work related to the centralized procurement of insulin would be started in September and implemented in early 2022, with a procurement cycle of two years.

In the view of the industry, the above-mentioned documents actually mean that biopharmaceutical centralized purchase will be the first to test water in the 27 billion yuan insulin market.

Previously, the National Health Insurance Bureau has repeatedly responded to the issue that biological agents and Chinese patent medicines are included in the national centralized purchase policy, emphasizing that they should be taken as much as possible. At a regular policy briefing held by the Information Office of the State Council on January 29 this year, Chen Jinfu, deputy director of the State Medical Insurance Bureau, said: it is an institutional requirement for large varieties of bio similar drugs, including Chinese patent medicines, to be included in the centralized procurement, but the rules will be more optimized, more targeted, and the quality will be more in line with the attributes of the drug itself.

Some people in the industry also pointed out that due to the particularity of biopharmaceutical products, the relevant elements included in the category of centralized purchase need to be clarified at this stage. Zhang Wenjie, executive director, chief executive officer and President of Fuhong Hanlin, told the 21st century economic news reporter that the centralized procurement of drugs is a gradual process of small molecules first and then large molecules. In the short term, similar anti-tumor biological drugs will not enter the national centralized procurement for the time being. Therefore, Fuhong Hanlin does not worry about the impact of biopharmaceuticals entering the centralized procurement on enterprise operation in the short term.

The key to the collection of biological similar drugs

Since 2018, the National Health Insurance Bureau, together with relevant departments, has actively promoted the reform of centralized drug procurement with quantity, and successfully carried out five batches of 218 drugs. Under the guidance and promotion of the National Health Insurance Bureau, all provinces in the country have carried out centralized drug procurement in the form of independent procurement or inter provincial alliance procurement.

With the accumulation of experience in drug centralized purchase, the policy of biopharmaceutical centralized purchase is also constantly promoted.

On July 15-16, 2020, relevant departments and offices of the State Medical Security Bureau held a forum to listen to experts' opinions and suggestions on centralized procurement of biological products (including insulin) and Chinese patent medicines, study and improve procurement policies in relevant fields, and promote the reform of procurement methods. The industry believes that insulin will not be included in the centralized collection.

On January 22, this year, the general office of the State Council issued the opinions on promoting the normalization and institutionalization of centralized drug procurement, which arranged and deployed the normalization and institutionalization of centralized drug procurement across the country and put forward work requirements.

At the regular policy briefing of the State Council, Chen Jinfu said: "there are differences in the quality evaluation methods of bio similar drugs and chemical drugs, but they have strict quality standards. It is beyond doubt that they will be included in the centralized purchase in the next step. Some places have been explored, and the quality of the selected products is completely controllable. Therefore, according to the No.2 document issued by the State Council of the people's Republic of China and the situation of exploration, it is a systematic requirement that biological similar drugs, including large varieties of Chinese patent medicines, be included in the centralized procurement. However, the rules are more optimized and targeted, and the quality is more in line with the attributes of the drug itself. "

So far, only chemical drugs are still listed in the list of five batches and six rounds of national procurement. It is pointed out that this is due to the special consideration of biological agents in the dimensions of similarity, stability, substitutability and enterprise capacity, which is an important reason why the State Medical Insurance Bureau has not launched the centralized procurement of biological agents for a long time.

In this regard, a senior person in the industry told the reporter of the 21st century economic report that all kinds of channels for the centralized purchase of biopharmaceuticals are basically open“ At present, from the system level, the state should take full advantage of the system; From the technical level, the national "guidelines for similarity evaluation and indication extrapolation technology of biological analogues" issued, which provides a relatively planned technical reference standard

Biosimilars are one kind of antibody drugs. Antibody drugs can be divided into original research drugs and biological analogues according to patents. Biosimilars refer to therapeutic biological products which are similar to the reference drugs (original research biopharmaceuticals) approved for marketing in terms of quality, safety and efficacy.

However, different from chemical generic drugs, biological macromolecular drugs have large molecular weight, complex structure, more difficult to characterize, high process sensitivity, unable to completely and accurately copy, can only achieve similarity, so it is called biological similar drugs. At the same time, due to the special composition, it is impossible to establish the drug consistency evaluation standard, which makes it more difficult to formulate the procurement policy with quantity.

At the beginning of this year, the drug examination center of State Food and Drug Administration issued a circular on the guiding principles of similarity evaluation and indication extrapolation technology of biologically similar drugs, further standardizing and guiding the research and development and evaluation of biological similar drugs, and providing technical reference for the industry, researchers and regulatory agencies Non clinical studies, clinical comparative studies and other evidence, comprehensive evaluation of biological drugs, so as to determine the overall similarity of biological similar drugs and the original research (Reference) drugs. This principle is regarded as the "consistency evaluation" principle of biological similar drugs by many people in the industry.

150 billion market structure changes

On July 28, the state medical insurance bureau held a forum on the reform of centralized insulin procurement to listen to the opinions and suggestions of relevant enterprises and industry associations. This move was interpreted by many industry insiders as the time has come for insulin to be included in the national intensive collection.

However, in the letter on the reply to the proposal No. 3013 (medical and sports 184) of the fourth session of the 13th National Committee of the Chinese people's Political Consultative Conference (CPPCC) on August 17, the State Medical Insurance Bureau once again responded: "the opinions of the general office of the State Council on promoting the normalization and institutionalization of centralized drug procurement" clearly proposed that we should adopt all measures. In the next step, we will combine the characteristics of biological agents in terms of similarity, stability and substitutability, consider the needs of clinical medication, fully solicit the opinions of clinical and pharmaceutical experts and relevant enterprises, find out the enterprise capacity, and form rules suitable for the characteristics of biological agents. "

In addition, on the evening of August 18, a letter about soliciting opinions on the national organization's centralized insulin procurement program (Draft) came out of the industry. Several insulin companies told the media that they had received the letter. According to the document, the work related to the centralized procurement of insulin was started in September and implemented in early 2022, with a procurement cycle of two years.

It is also considered that the state will first test the water biopharmaceutical collection through the 27 billion yuan insulin market.

In fact, in the domestic market, the market sales of biological drugs are also growing rapidly. According to the data of MI Nei net, in 2020, the sales volume of biopharmaceuticals in China's public medical institutions will be close to 150 billion yuan, with a year-on-year growth of 12.6%. The proportion of sales volume will also rise from 9.2% in 2019 to 11.8%, constantly narrowing the gap with Chinese patent medicines.

In recent years, domestic pharmaceutical companies such as Fuhong Hanlin, Haizheng pharmaceutical, baiaotai, Qilu and Xinda biology have also developed similar biological drugs, including "well-known large varieties" adamumab, bevacizumab, rituximab, trastuzumab, etc.

Especially in 2019, breakthrough progress has been made in the field of biological analogues in China.

Hanlinhanlikang in 2019 ? After being approved for marketing, adalimumab injection (trade name: gelolide) developed by baiaotai biological Co., Ltd ?）、 Adalimumab injection developed by Haizheng Pharmaceutical Co., Ltd ?） Bevacizumab injection developed by Qilu Pharmaceutical Co., Ltd ?） It was also approved for listing on November 7, December 6 and December 9, 2019.

Jin Chunlin, director of Shanghai Health and health development research center, said in an interview with 21st century economic reporter that the development of biological analogues in recent two years has been very fast. In addition to those approved for listing, there are about 100 biological similar drugs under research in China. However, we should avoid enterprises rushing to biological similar drugs and lay out the same track, which leads to repeated investment and construction.

At the same time, Tao Libo, a researcher at the center for health policy and technology evaluation of Peking University Medical Department, once wrote that the core concept of centralized purchase with volume is "trading for price with quantity". The buyer will offer huge future sales volume in exchange for the manufacturer's lowest quotation. There may be contradictions: the lower the quotation, the easier it is to win the bid. However, the greater the pressure on the manufacturer's cost, the higher the supply volume to be completed, and the greater the risk of supply difficulties. In the field of biopharmaceuticals, due to the complexity of the process, the pressure of production capacity and supply will be greater than that of chemical drugs, and the risks will be more obvious.

In Zhang Wenjie's opinion, under the background that the national system should be fully adopted, the centralized collection of biological similar drugs is an inevitable trend, but it will also advance gradually like chemical drugs.

"Centralized drug procurement is a gradual process of small molecules first and then large molecules. In the short term, anti-tumor biological generic drugs will not enter the national centralized procurement for the time being. China has a high degree of differentiation of insulin and huge price difference, and the research and development cost and production cost of insulin are far lower than the latter; In addition, the production capacity construction time of small molecule drugs is relatively short, which is greatly affected by the centralized purchase policy. However, the investment cost of the production capacity construction of macromolecular drugs is high, and it is difficult to double rapidly because of the introduction of centralized procurement. " Zhang Wenjie pointed out to the 21st century economic reporter.

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