The National Medical Insurance Bureau releases the signal of centralized collection of biological drugs again!

The industry can already hear the footsteps of biopharmaceutical gathering

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

The biopharmaceutical market is close to 150 billion yuan

At present, biopharmaceuticals have become a hotspot in the global pharmaceutical industry competition and the main direction of China's strategic emerging industries

Proportion of sales of various drug types in China's public medical institutions in 2020

Data source: Mi Nei.

The reasons for the increasing proportion of biological drugs 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, the anti-epidemic varieties in biological products (such as interferon) , Immunoglobulins in blood products, etc.

TOP20 Terminal Western Medicine Products of China's Public Medical Institutions in 2020

Data source: Mi Nei.

Among them, the most interesting ones are trastuzumab, bevacizumab, and rituximab, the three major anti-tumor biologics that have made the list

The size of bevacizumab's terminal market in China's public medical institutions will reach 4.

In 2020, the rituximab market in China's public medical institutions will reach 4.

More experience is still needed for the collection of biopharmaceuticals

If chemical drugs meet the "1+2" ​​competition pattern, they can be included in the national procurement threshold.

China's approved monoclonal antibody biosimilar drugs and their original research products

In addition to meeting the requirements of full competition, the chemical drugs included in the centralized procurement also need to pass or be deemed to have passed the consistency evaluation

In February of 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)".

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.

Whether the production enterprises can guarantee the supply is also a major test for the entry of biological agents into the national procurement catalog

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

Rules for the centralized procurement of biological preparations for testing water with insulin

Insulin may test the water first to explore the rules of centralized procurement of biological preparations

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 generally did not change the market competition pattern
.

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%
.

Top 10 brands of terminal insulin and similar drugs in China's public medical institutions in 2020

Source: Mi Nei.
com, China's public medical institutions terminal competition pattern

At present, there are more than 50 local pharmaceutical companies in the domestic insulin track.
For these pharmaceutical companies, if they cannot enter the centralized procurement, it may mean that they lose their existing market share; but if they enter the centralized procurement, how to determine the price reduction rate It has become a problem to balance market share and corporate profits
.
From the perspective of relatively competitive second-generation insulin, the domestic production technology is already mature.
Compared with foreign companies, the production cost is lower, and the probability of achieving domestic substitution is relatively high.
However, the production technology requirements of the third-generation insulin are relatively high, and the domestic 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, in reply to the recommendation No.
6450 of the Third Session of the 13th National People’s Congress, stated 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
.