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

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

Data source: Mi Nei.

2020 China's public medical institutions' terminal Western medicine TOP20 productdata source: Mynet.

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

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)".

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

  Earlier, Wuhan, Hubei, had conducted a pilot project for centralized insulin procurement

  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 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, 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
.