The eighth batch of national biosimilar conjectures

With the orderly advancement of the normalization and institutionalization of drug centralized procurement, the call for biosimilars to be included in national centralized procurement is getting louder
and louder.
All indications are that biosimilars are on the line
.
The National Health Insurance Administration has repeatedly released the intention of "including biosimilars in centralized procurement with volume"; The sixth batch of special insulin collection launched the "first shot" of biological drug procurement; The National Health Insurance Administration mentioned in its reply to the proposal of CPPCC members that it will combine the characteristics of biological drugs and continuously improve the rules for the collective procurement of
biological drugs.

 

According to industry news, the eighth batch of national procurement will still be dominated by chemical drugs, or there will be sporadic "cameos"
of biological drugs.
So, which biosimilars are expected to be included in the eighth batch of national procurement?

 

Which ones were included in the national procurement first?

 

As of November 9, 2022, the biosimilar drugs approved in China are: adalimumab, bevacizumab, denosumab, rituximab, trastuzumab, and infliximab
.

 

According to PDB data, in 2021, the sales of bevacizumab sample hospitals will be 2.
466 billion yuan (the magnification of anti-tumor drugs in 2021 is 2.
29, which is enlarged to 2.
466 billion yuan in public hospitals nationwide×229 is about 5.
647 billion yuan, the same below).

The sales of trastuzumab sample hospitals was 1.
723 billion yuan, although the market is also large, but only one company has obtained biosimilar approval, so it is unlikely that this variety will be included in this collection
.
The sales of denosumab are small, and only 1 company has been approved, so it is unlikely to be included in this collection
.
Rituximab has a large sales volume, with 2 biosimilar approvals obtained, plus 1 original researcher, for a total of 3
.
The sales of infliximab sample hospitals was 336 million yuan (the magnification of bone and muscle drugs in 2021 was 2.
89, which was enlarged to 336 million yuan in public hospitals nationwide ×289 was about 971 million yuan, the same below), adalimumab also had similar sales, and these two drugs contained original research approvals of 4 or more
.

 

If there are really biological drugs included in the eighth batch of national procurement, then the probability of biological drugs that have been approved by 3 or more is relatively high
.
Therefore, the four varieties most likely to be included in this collection are bevacizumab, rituximab, infliximab and adalimumab
.

 

The head player is basically formed

 

In addition to the above 4 varieties that are most likely to be included in the centralized procurement, trastuzumab, which has relatively large sales, should be ranked in the second echelon
.
The sales amount of this drug in 2021 will increase by 13.
7% compared with 2020, and once one or more new biosimilars are approved and meet the conditions of "3 or more listed manufacturers (including original research)", it is very likely to enter the subsequent national centralized procurement
.

 

According to Yaodu data, by the end of 2021, the number of biosimilar R&D pipelines in China was 391, and there were nearly 180 biosimilar enterprises in China
.

 

It can be predicted that after the procurement is landed, there will not be many companies that really have the ability to supply a "basket" of biosimilars at a long-term low price, and the head players will basically take shape
.
In the future, many varieties, large production capacity and low cost will become the magic weapon of the domestic biosimilar market, and it is expected that the result of "the leftover is king" will
appear.

 

 

Enterprise strategy <<<

 

The degree of domestic substitution? Bidders' willingness to cut prices?

 

For the several varieties that are most likely to be included in the national procurement, what is the willingness of enterprises to bid?

 

The author analyzes the listed manufacturers, sales amount and unit price, and predicts that the attitude of relevant enterprises is: the original research drug company will most likely choose to abandon the bid; Domestic biosimilar enterprises that already have a certain market share will participate in the bidding, but the quotation may be conservative; In order to seize the hospital market, the quotations of new entrants will be more aggressive, which will promote a new low
in centralized procurement bidding.

 

The different degrees of domestic substitution will affect the willingness of enterprises to bid
.
The degree of domestic substitution of several varieties was arranged from high to low, namely bevacizumab, rituximab, adalimumab, and infliximab, and the replacement rates were about 75%, 49%, 40% and 0.
8%,
respectively.

 

Replace mature people with many to grab bids

 

The domestic biosimilars of bevacizumab have gradually completed the substitution
of imports.
In the first half of 2022, the sales amount of domestic Qilu Pharmaceutical has exceeded that of imported original research Roche, accounting for more than half
.
Roche's share fell to 25.
3%
from 70.
8% in 2020.

 

According to the PDB database, the sales amount of bevacizumab injection in the sample hospitals in the first half of 2022 was 1.
227 billion yuan, an increase of about 4.
2% year-on-year; The number of sales increased by 10.
8%
year-on-year.
There are 8 sales manufacturers, 1 is an imported pharmaceutical company, and 7 are domestic pharmaceutical companies
.
In addition to Henlius, other companies that have obtained biosimilar approvals have shown sales, especially the top two approved in China, Qilu Pharmaceutical and Innovent Biologics, accounting for about 70%
of the total sales amount.

 

From the price point of view, Roche's products with the same specifications are about 30% higher than domestic Qilu and Innovent products, while the newly approved Dongyao Pharmaceutical biosimilar price is only 655.
8 yuan, which is 0.
56 times the price of Qilu, which shows its determination
to quickly occupy the market at a low price.

 

Bevacizumab injection is a national medical insurance category B catalog
.
If the variety is included in the national centralized procurement, it can be predicted that Roche may abandon the bid, but there will be a number of rush bids, Qilu and Cinda, which already have a certain share of the market, may be conservative, and the bidding of Dongyao Pharmaceutical, Suzhou Shengdia, Bio-Thera and other new entrants to the market will be more aggressive
.

 

Replacing nearly half of the decline in sales

 

Take rituximab as an example
.
In the first half of 2022, the sales amount of rituximab injection in the sample hospitals was 693 million yuan, down about 5.
5% year-on-year, but the sales volume increased by 4.
9% year-on-year, mainly due to the lower
prices of newly listed domestic products.
In the first half of 2022, there are 3 sales manufacturers, 1 is an imported pharmaceutical company, 2 are domestic pharmaceutical companies, and the sales amount of 2 local pharmaceutical companies has accounted for nearly 50% of the market
of public hospitals.

 

In the first half of 2022, the sales of Henlius, the first domestic biosimilar to be marketed, in the 10ml:0.
1g specification have exceeded the imported original research Roche and its subsidiary Genentech.

The proportion of Roche's two specifications decreased from 71.
1% in 2020 to 50.
9%.

 

From the price point of view, the price of Roche 10ml:0.
1g specification is about 64% higher than that of the domestic Henlius, while the average price of the newly approved Innovent Biosimilar is only 1072.
6 yuan, which is 0.
77 times
the price of the domestic Henlius.

 

The proportion of domestic production is small, and the bidding space is large

 

In the first half of 2022, the sales amount of injectable infliximab sample hospitals was 167 million yuan, an increase of about 7.
3% year-on-year, and the number of sales increased by 8.
2%
year-on-year.
In the first half of 2022, there are 3 sales manufacturers, 1 is an imported pharmaceutical company, 2 are local pharmaceutical companies, except for the recently approved Yuxi Jiahe Biotechnology, the other 2 companies that have obtained biosimilar approvals have shown sales, but the proportion is very small
.

 

In the first half of 2022, Janssen Biologics' imported infliximab for injection accounted for 99.
2% of the sales amount, occupying an absolute share of
the market.
From the price point of view, the price of Janssen Biotech with the same specifications is more than 50% higher than
that of the domestic two.

 

If imported drugs abandon the bid, Hisun Biologics, Maibotike Pharmaceutical and Yuxi Jiahe Biotechnology face almost the entire market of this variety, it can be said that there is a lot of bidding space, and the price reduction is worth paying close attention
to.