Bio-macromolecular Drugs in the Autoimmune Disease Field in China

Henlius, a subsidy of Fosun Pharmaceutical, filed a marketing application: CXSS1900001 for adalimumab biosimilar on Jan. 24, 2019, being the 4^th marketing application filed for adalimumab biosimilar in China and leading to the 2^nd biosimilar of Henlius in the marketing review stage.

AbbVie released its 2018 financial report on Jan. 25, 2019, according to which, the 2018 sales of Humira reached USD19.936 billion, securing its position as the global drug king and topping for seven times in terms of sales!

Here, we'll focus on the bio-macromolecular drugs in the autoimmune disease field that have been marketed or in the marketing review stage in China, overall, including 9 marketed drugs and 6 drugs in the marketing review.

Overview of bio-macromolecular drugs in the autoimmune disease field in China

There have been 8 bio-macromolecular drugs marketed in the autoimmune disease field in China by Jan. 27, 2019, wherein, in 2005, Sunshine Guojian's Yisaipu (etanercept) was the first drug marketed, and there are 5 imported drugs and 3 Chinese-produced drugs, with all Chinese-produced varieties being biosimilars, as shown in the following table:

In the international market, sales of adalimumab, etanercept, infliximab, ustekinumab, and abatacept separately reached USD18.4 billion, USD7.89 billion, USD7.76 billion, USD4.01 billion, and USD2.479 billion in 2017.

However, imported varieties have high prices but poor patients-awareness rate and market penetration after entering China; Sunshine Guojian's Yisaipu has the first-mover advantage as a Chinese-produced variety, and has been included in the medical insurance, enjoying absolute dominant status in the rheumatoid arthritis, ankylosing spondylitis, and psoriasis field. Hospital medical supply companies are doing a great job in this field.

Specifically,

Sunshine Guojian's Yisaipu has been marketed in China early with a low price; its sales reached RMB1.01 billion and market share reached 60% in 2017, occupying the absolute advantage. And Chinese-produced varieties like Qiangke and Anbainuo still enjoy growth prospects. All these 3 Chinese-produced etanercept biosimilars will gradually nibble the market share of the original drug Enbrel.

Market shares of imported varieties in the field of bio-macromolecular drugs for autoimmune diseases have not been good and continue to be nibbled. Relatively, the market performance of Remicade is good in the field, which is priced at RMB90,000/year and relatively convenient to use, with the market share stabilizing at about 20%.

The market share of Yisaipu will be gradually squeezed with the improvement of patients-awareness rate and ability to pay, and the bio-macromolecular drugs with better compliance and better safety will become the mainstream in the market.

In addition to the 8 bio-macromolecular drugs marketed, there are 8 bio-macromolecular drugs in the marketing review stage, wherein, the marketing application for the infliximab biosimilar of Zhangjiang Biotechnology/Biomabs has been withdrawn.

Secukinumab is the one with the most exceptional efficacy among the 8 bio-macromolecular drugs in marketing review in China, with striking performance in global market; it is expected to be approved in China in 2019.

Related:

Humira Topped for Seven Times in Sales and Remaining Global Drug King

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