​One article to understand the competitive landscape of the domestic biosimilar drug market

Since 2015, with the introduction of a series of policies by the state to encourage the development of domestic biosimilars, many returnee doctors have returned to China to start businesses, and many investment institutions have poured funds into the biosimilar drug mark.

In recent years, domestic pharmaceutical companies have set off round after round of drug research and development, from the development of monoclonal antibody biosimilars, to the development of monoclonal antibody innovative drugs, and now the development of bispecific antibody drugs and antibody conjugated drugs is in full swi.

This article focuses on the development status of domestic biosimilars in the past few yea.

Domestic biosimilars usher in a competitive landscape of blooming flowers

At present, there are six biosimilars listed by domestic pharmaceutical companies: bevacizumab, adalimumab, trastuzumab, rituximab, denosumab and infliximab (see Table

It can be seen from Table 1 that:

Henlius and Chia Tai Tianqing each have 4 biosimilars approved or declared for marketing, and they are in the first echelon ;

Innovent Bio and Hisun Pharmaceutical also have 3 biosimilars that are in the state of approval or application for marketing, and are in the second echelon;

Qilu Pharma, Luye Pharma, Bio-Tech and Shenzhou Cell all have 2 biosimilars that are in the state of approval or application for marketing, and are in the third echelon ;

Subsequently, Betta Pharmaceuticals, Dongbiao Pharmaceuticals, Hengrui Pharmaceuticals, Junshi Bio, Anke Bio, Taikang Bio, Jiahe Bio, and Maibo Pharmaceuticals all have one biosimilar drug that has been approved or declared for marketi.

Domestic biosimilars have achieved good sales performance after the listing

Since the first domestic biosimilar variety was launched in 2019, many biosimilars have been listed one after anoth.

Henlius

Henlius developed the first biosimilar drug on the market in China, Hanlikang (rituximab biosimilar) , which was approved for marketing in February 201 Since its launch three years ago, its sales revenue has reached RMB 79 million and RMB 288 million respective.

Hanquyou (trastuzumab biosimilar) was approved for marketing in August 2020, with sales revenue of 109 million and 868 million respectively in the two years since its launch;

Handayuan (Adamus biosimilar drug) was launched in December 2020, and the sales revenue in the two years since its launch was 02 million and 218 million yuan respective.

Since the launch of the above three drugs, the sales revenue has achieved a great growth rate, and the gross profit margin is also above 6

Innovent Bio

Innovent currently has three biosimilars on the mark.

At present, since the three biosimilars have been on the market for more than a year, the sales revenue in 2020 and 2021 will reach about 80 million and 2 billion, respectively, and the gross profit margin is about 86%, all of which have achieved rapid performance grow.

Bio-Tech

Bio-Tech Biotech currently has two biosimilars approved for marketi.

Judging from the sales performance of the currently listed biosimilar drugs, they have achieved doubled performance growth, and the gross profit margin is quite hi.

What is the prospect of the domestic biosimilar drug market?

At present , domestic and foreign pharmaceutical companies are not optimistic about the development prospects of the biosimilar busines.

In recent years, with the intensified competition in the international biosimilar drug market and the increase in patent litigation disputes, many foreign pharmaceutical companies have realized that biosimilar drugs are a business with high input costs and limited profi.

With the continuous advancement of centralized drug procurement in China, the state currently organizes 6 batches of centralized drug procurement, purchasing a total of 234 kinds of drugs, and the market value involved accounts for about 30% of the purchase amount of chemical drugs and biological drugs by public medical institutio.

From the perspective of procurement varieties, the three major pharmaceutical sectors of chemical medicine, Chinese patent medicine and biological medicine are all involv.

In the future, centralized drug procurement will be carried out in a normalized and institutionalized mann.

It is expected that by the end of this year, the total number of national and provincial centralized drug procurement will reach more than 350 in each provin.

At present, from the biosimilar varieties that have been listed or declared for marketing in China:

10 pharmaceutical companies for bevacizumab have been approved or declared for listing; 8 pharmaceutical companies have been approved or declared for adalimumab; 5 pharmaceutical companies have been approved or declared for trastuzumab Listed; rituximab, denosumab, and infliximab all have 4 pharmaceutical companies approved or declared for marketi.

Judging from the number of approved manufacturers of biosimilars, some varieties do meet the national centralized drug procurement requiremen.

It is expected that in the next five years, domestic biosimilars will encounter fierce market competition, and it is very likely to usher in national drug concentrati.

Procureme.

However, it is not necessary to be too pessimistic about the prospects of the domestic biosimilar drug mark.

Biosimilar drug research and development is a business with high technical barriers and high investme.

At the same time, biosimilar drugs also encounter the problem of non-interchangeabili.

It is easy to change biosimilar manufacturers , which is also a barrier for biosimilars to be sold in the mark.

From the perspective of the R&D pipeline layout of domestic pharmaceutical companies since the country launched centralized drug procurement in the past three years, many pharmaceutical companies are actively deploying bispecific antibody business, multispecific antibody business, antibody conjugated drug business, and biosimilar drug busine.

There are very few pharmaceutical companies in the pipeli.

For pharmaceutical companies with biosimilar drug development capabilities, the current layout of differentiated biosimilar drug pipelines has certain development prospec.

References:

Annual reports of Henlius, Innovent Bio, Biotech, Hisun Pharmaceutical;

Biosimilars will usher in intensive listi.

Antibody Circle, 202012;

Biosimilars are being abandoned by multinational pharmaceutical compani.

Health Knowledge Bureau, 202008;