Competitive Landscape of China's Biosimilars 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 market. Domestic biopharmaceuticals have made great progress, and many biological Technology companies, and even many biotech companies, have gradually developed into biopharmaceutical companies.

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 swing. Such remarkable progress in a very short period of time.

This article focuses on the development status of domestic biosimilars in the past few years. If there are any shortcomings, you are welcome to point out.

China's biosimilars usher in a competitive landscape of blooming flowers

Currently, there are six biosimilars listed by domestic pharmaceutical companies: bevacizumab, adalimumab, trastuzumab, rituximab, denosumab and infliximab.

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 marketing.

Domestic biosimilars have achieved good sales performance after listing

Since the first domestic biosimilar drug variety was launched in 2019, many biosimilars have been listed one after another. It is expected that from 2022 to 2024, these three years will usher in a climax of domestic biosimilars, and domestic biosimilars have already been listed. How did the market perform after the listing? Below we will focus on the market performance of Henlius, Innovent and Bio-Tech, the biosimilar business of these three companies.

Henlius

Henlius developed the first biosimilar drug on the market in China, Hanlikang (rituximab biosimilar), which was approved for marketing in February 2019. Since its launch three years ago, its sales revenue was RMB 79 million and RMB 288 million respectively. and 542 million;

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 01.2 million and 218 million respectively.

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 68%.

Innovent Bio

Innovent Bio currently has three biosimilars on the market. Currently, Dayoutong (bevacizumab biosimilar) was approved for marketing in June 2020, and Surison (adalimumab biosimilar) was approved for marketing in 2020. Approved for marketing in September, Dabohua (rituximab biosimilar) was approved for marketing in September 2020.

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 1.2 billion, respectively, and the gross profit margin is about 86%, all of which have achieved rapid performance growth.

Bio-Tech

Bio-Tech Biotech currently has two biosimilars approved for marketing. Geleli (Adalimumab biosimilar) was approved for marketing in November 2019, and Pubexi (bevacizumab biosimilar) was approved for marketing in November 2019. Approved for listing in November 2021. The sales revenue of Geleli in the two years since its listing was 182 million and 306 million respectively, with a gross profit margin of 84%, which has achieved good performance growth.

Judging from the sales performance of the currently listed biosimilar drugs, they have achieved doubled performance growth, and the gross profit margin is quite high. The pharmaceutical companies in the biosimilar drug business with the first-mover advantage have achieved good advantages. It is expected that the next In 5 years, biosimilars will usher in a peak in sales performance, and at the same time, they will encounter fierce market competition.

What is the prospect of the domestic biosimilar market?

At present, domestic and foreign pharmaceutical companies are not optimistic about the development prospects of the biosimilar business. In January this year, Bojian issued an announcement to sell the shares of Samsung Bio to withdraw from the biosimilar business. At present, Samsung Bio owns ranibizumab, bevacizumab, Trastuzumab, adalimumab, infliximab and etanercept are six biosimilars.

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 profits. Since 2017, Pfizer, Merck, Sandoz, Merck, Boehringer Ingelheim and other companies have gradually abandoned some biosimilar business.

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 institutions. At the end of last year, the special procurement of insulin was launched, and the centralized procurement was expanded from chemical drugs to biological drugs for the first time. At present, the seventh batch of centralized procurement is about to be launched. Local governments also actively carry out centralized procurement of medicines and consumables as required, and all provinces have carried out centralized procurement of medicines and consumables through provincial or inter-provincial alliances.

From the perspective of procurement varieties, the three major pharmaceutical sectors of chemical medicine, Chinese patent medicine and biological medicine are all involved. In the future, centralized drug procurement will be carried out in a normalized and institutionalized manner. 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 province.

Judging from the varieties of biosimilars that have been listed or declared for marketing in China:

Bevacizumab has been approved or declared for listing by 10 pharmaceutical companies;

Adalimumab has been approved or declared for listing by 8 pharmaceutical companies;

5 pharmaceutical companies for trastuzumab have been approved or applied for listing;

Rituximab, denosumab, and infliximab each have 4 pharmaceutical companies approved or declared for marketing.

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

However, it is not necessary to be too pessimistic about the prospects of the domestic biosimilar drug market. Biosimilar drug research and development is a business with high technical barriers and high investment. At the same time, biosimilar drugs also encounter the problem of non-interchangeability. It is easy to change biosimilar manufacturers, which is also a barrier for biosimilars to be sold in the market.

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 business. There are very few pharmaceutical companies in the pipeline. For pharmaceutical companies with biosimilar drug development capabilities, the current layout of differentiated biosimilar drug pipelines has certain development prospects.