Re-release the signal of collection of biological drugs!

Medical Network, August 23, the industry has heard the footsteps of the collection of biological drugs
.
Recently, the National Medical Insurance Bureau stated in the "Letter on Proposal No.
3013 (Medical Sports No.
184) of the Fourth Session of the 13th CPPCC National Committee" that the "biological agent procurement mechanism" stated that it would combine the similarity of biological agents.
, Stability and substitutability and other aspects, consider the needs of clinical medication, fully solicit the opinions of clinical and pharmaceutical experts and related enterprises, find out the production capacity of the enterprise, and form rules suitable for the characteristics of biological preparations
.
Under the baton of the top level of the country that it should be fully collected, biological agents will obviously not be the exception category in the wave of volume procurement
.
However, based on the particularity of the objective existence of biopharmaceutical products, the relevant elements included in the centralized procurement category still need to be specifically clarified at this stage
.
However, there is no doubt that once the key information is clarified, the centralized procurement of biological drugs will inevitably come with a price reduction that is similar to that of chemical drugs
.

The biopharmaceutical market is close to 150 billion yuan.

At present, biopharmaceuticals have become a hot area of ​​competition in the global pharmaceutical industry and the main direction of China's strategic emerging industries
.
In the international market, biopharmaceuticals are gradually surpassing chemical medicines and are promoted to become the largest pillar area of ​​the global pharmaceutical market.
This is reflected in the fact that biopharmaceuticals sit on half of the global best-selling drug list
.
In the domestic market, the market sales of biopharmaceuticals are also achieving rapid growth
.
According to data from Mi Nei.
com, in 2020, the sales of biopharmaceuticals in China's public medical institutions will be close to 150 billion yuan, an increase of 12.
6% year-on-year.
The proportion of sales also increased from 9.
2% in 2019 to 11.
8%, and the relationship with Chinese patent medicines is constantly shrinking.
Gap
.
2020 Chinese public medical institutions terminal drugsSources of data on the proportion of sales by type: Mynet.
com.
China’s public medical institutions’ terminal competition pattern.
The reasons for the increasing proportion of biomedicine in the hospital market in China are that, firstly, in recent years, there are relatively more innovative drugs on the market in biological products, especially Anti-tumor antibody drugs; second, anti-epidemic species in biological products (such as interferon, immunoglobulin in blood products, etc.
) and heavy anti-tumor species have greater market demand, and related drugs are used in clinical practice
.
In the list of TOP20 products of terminal western medicines in China's public medical institutions in 2020, human albumin, intravenous human immunoglobulin (pH4), insulin aspart, trastuzumab, bevacizumab and rituximab Other biological drugs are among them
.
Data source of the TOP20 products of China's public medical institutions' terminal Western medicines in 2020: Mynet.
com China's public medical institutions' terminal competition pattern.
Among them, the most interesting ones are trastuzumab, bevacizumab and rituximab.
The anti-tumor biologics on the list
.
According to data from Meinnet.
com, in 2020 China's public medical institutions, although sales of trastuzumab for injection have declined slightly, there is still a market size of more than 5 billion yuan
.
At present, the only manufacturers of this product are Roche and Fuhong Henlius
.
Although Roche currently has the largest market share, the latecomer, Fuhong Hanliu, is gaining momentum.
Hanquyou, which was approved to be listed in Central Europe in the third quarter of 2020, earned a total of 136 million yuan in revenue last year, while only domestically in the first half of this year.
Revenue has grown to 287.
6 million yuan
.
The size of bevacizumab's terminal market in China's public medical institutions will reach 4.
62 billion yuan in 2020, a year-on-year increase of 34.
88% from 3.
43 billion yuan in 2019
.
Roche, the original research drug company, is still the leading company for the product, but under the impact of biosimilar drugs from Qilu, Xinda, and Luye, its market share in public hospitals in key provinces and cities has begun to decline, with sales year-on-year Down more than 15%
.
It is reported that Qilu Pharmaceutical's bevacizumab injection was approved for listing at the end of 2019, but its sales in China's public medical institutions in 2020 have exceeded 1.
5 billion yuan, and its market share is estimated to exceed 30%
.
In 2020, the rituximab market in China's public medical institutions will reach 4.
36 billion yuan
.
Although the original research drug company Roche still occupies an important market share, as the rituximab biosimilars of Fuhong Henlius and Cinda Biologics have been approved one after another, the market competition landscape has changed
.
Among them, Han Likang of Henlius, as China's first rituximab biosimilar, was approved in March 2019.
In 2020, its sales in public medical institutions in China will exceed 700 million yuan
.
As the second domestically produced rituximab, Dabohua of Cinda Biotech was approved in October 2020.
Although specific sales data have not yet been disclosed, the commercialization of Sintilimab, a PD-1 inhibitor, is the second Judging from the revenue achievement of 2.
29 billion yuan in the year, Dubohua has the same prospects
.

　　Biopharmaceuticals still need to accumulate more experience.

If chemical drugs meet the "1+2" ​​competition pattern, they can be included in the national procurement threshold.
In fact, there are many varieties of biological agents that meet the requirements, but five batches have been launched so far.
In the six rounds of national procurement lists, only chemical drugs are still listed
.
Some opinions point out that the special considerations of the similarity, stability, substitutability, and enterprise capacity of biological preparations are the important reason why the National Medical Insurance Bureau has not started the centralized procurement of biological preparations
.
In addition to meeting the requirements of full competition for the monoclonal antibody biosimilar drugs approved in China and their original research products, the chemical drugs included in the centralized procurement also need to pass or deemed to pass the consistency evaluation
.
Some people in the industry pointed out that, like chemical drugs, biological preparations also have the difference between original research and imitation, but because biological macromolecules cannot achieve the same structure as chemical molecules, they are named biological analogs
.
Although different countries have different definitions of biosimilars, they all require a certain degree of similarity with the reference original drug in terms of quality, safety and effectiveness.

.
In February this year, CDE issued the "Technical Guidelines for the Evaluation of the Similarity of Biosimilars and the Extrapolation of Indications", which further supplemented the "Guiding Principles for the Development and Evaluation of Biosimilars (Trial)".
Guiding suggestions for extrapolation of indications to further standardize and guide the development and evaluation of biosimilar drugs
.
Later, CDE has successively issued clinical guidelines for biosimilars such as liraglutide, trastuzumab, rituximab, adalimumab, and bevacizumab.
Validity comparison studies, safety and immunogenicity studies and other evaluation indicators of the clinical experimental design and end points are explained, and the main research end points are recommended for each drug
.
Some analysts believe that in the evaluation of the similarity between biosimilar drugs and original research drugs, policy norms are currently becoming clear and quantified.
There are already clear standards for large varieties such as monoclonal antibodies, and they have the prerequisite for clinical substitution.
Condition
.
The issuance of a series of policies also means that the centralized procurement of biological products has been incorporated into the planning of the pharmaceutical policy.
With the progress of the evaluation of the similarity of biological similar drugs, its mass procurement will inevitably advance in an orderly manner
.
Whether the production enterprises can guarantee the supply is also a major test for the entry of biological agents into the national procurement catalog
.
Under the wave of industrial transformation and upgrading, local pharmaceutical companies have moved from the generic drug field to the innovative drug field, with the active deployment of bio-innovative drugs as the main focus
.
In order to effectively ensure a continuous and stable market supply, relevant pharmaceutical companies are fully expanding their production capacity
.
In 2020, Hanli Kang’s application for increasing the production scale of 2,000 liters of original solution and 2,000 liters of production equipment has been approved by the State Food and Drug Administration.
At present, its Xuhui production base has two production lines in the north and south, with 6 large-scale production lines of 2000 liters.
Large-scale disposable bioreactor
.
In the same year, Cinda's total production capacity was also successfully expanded from 5,000 liters to 24,000 liters
.
On the whole, it seems that China’s biologics/biosimilars still need to accumulate more experience in terms of supply stability and substitutability, and they do not fully meet the requirements for inclusion in national procurement
.
Some researchers pointed out that the procurement policy for biological products should also fully consider key information such as the product characteristics, industrial development stage, clinical needs, and patient safety of biological products to reduce potential drug safety risks for patients and explore innovative procurement policies suitable for biological products
.

　　Use insulin to test the rules of centralized procurement of biological preparations.

Insulin may be tested first to explore the rules of centralized procurement of biological preparations
.
In the "National Organization of Insulin Concentrated Procurement Plan (Draft for Comment)" released this week, the second-generation and third-generation insulins are divided into three groups according to quick-acting, basic and pre-mixed respectively, under the name "enterprise + generic name".
Compete for the unit, and fair competition among the generic products in the same group
.
Medical institutions report the demand for the next year based on the generic name of each group and each brand
.
The selected companies allocate the agreed procurement volume according to the quotation level, and the overall requirement is to appropriately increase the selection rate to promote more companies with more suitable quotations to be selected
.
However, it is not clear how the third-generation insulin is selected, how the exclusive specifications can meet clinical needs, and who pays for the related costs of insulin injections
.
Earlier, Wuhan, Hubei, had conducted a pilot project for centralized insulin procurement
.
Judging from the procurement documents, the rules for the national procurement of insulin and the centralized procurement of insulin in Wuhan are slightly different.
The latter is based on the price reduction to determine the market share: if the quotation is less than 5% of the national provincial-level online minimum price, the corresponding product will be released in 2018 70% of the annual purchase volume in Wuhan is the agreed purchase volume; if the quotation is less than 10% of the national lowest price, 90% of the product purchased in Wuhan in 2018 can be obtained
.
In the end, Wuhan contributed to a partial bid with a total purchase volume of 1,705,700, and the unit price of the product fell by as much as 43%
.
Novo Nordisk has won the most bids for products, followed by Sanofi and Eli Lilly.
The three major foreign companies accounted for 68% of the market, and the overall market competition has not changed.

.
According to data from Menet.
com, the sales of insulin and its similar drugs in the domestic market have continued to rise in recent years.
In 2020, the terminal sales of public medical institutions in China will be close to 27 billion yuan
.
Among them, Novo Nordisk, Sanofi, and Eli Lilly have long dominated the three major multinational pharmaceutical companies, with a combined market share of more than 70%; while the three domestic pharmaceutical companies of Ganli Pharmaceutical, Tonghua Dongbao, and United Laboratories are struggling to catch up.
The market share of Li Pharmaceuticals successfully exceeded 10% in 2020, and it is expected to surpass Eli Lilly and become the top three in the future
.
According to statistics from Meinenet, the total market share of TOP10 brands of terminal insulin and similar drugs in China's public medical institutions exceeds 80%.
Novo Nordisk has as many as 4 brands on the list.
15%
.
2020 China's public medical institutions' terminal insulin and similar drug brands TOP10 Source: Meinenet.
China's public medical institutions' terminal competition pattern.
At present, there are more than 50 domestic pharmaceutical companies that have an insulin track in China.
For these pharmaceutical companies, if they can't enter Centralized sourcing may mean losing the existing market share; but if entering centralized sourcing, how to determine the price reduction range to balance market share and corporate profits becomes a difficult problem
.
From the perspective of relatively fully competitive second-generation insulin, domestic production technology is already mature, and compared with foreign companies, the production cost is lower, and the probability of achieving domestic substitution is relatively high; however, the production technology requirements for third-generation insulin are relatively high, and domestically involved There are fewer manufacturing companies, and in combination with the distribution rules, the incremental part is allocated by the medical institutions independently selecting the winning bidders.
Medical institutions may be more inclined to continue their original clinical habits and choose imported products
.
According to industry insiders, it is still unclear whether insulin can complete the import substitution, coupled with the emergence of new hypoglycemic drugs one after another, local pharmaceutical companies may face a cold winter
.
As early as October last year, the National Medical Insurance Administration stated in its response to Recommendation No.
6450 of the Third Session of the Thirteenth National People’s Congress that it was studying policies related to the centralized procurement of biological products.
Based on factors such as the similarity of drugs, the stability of the company’s production capacity and supply chain, and the clinical substitutability of specific products, centralized procurement will be carried out in a timely manner.

.
In the blink of an eye for nearly a year, the National Medical Insurance Administration finally launched a pilot test for the centralized procurement of insulin.
Regardless of the results, it will accumulate certain experience for more centralized procurement of biological agents in the future, and how the final "rules of the game" will be formulated? Wait for the back view
.