Biosimilar monoclonal antibodies in China

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Biosimilar monoclonal antibodies (mAbs) are currently a major focus of research and development in China with policies support. mAbs have become crucial therapeutics for treating diseases such as oncology and autoimmune diseases. As competition from biosimilars increases in China, the price of mAbs is decreasing and access to them is increasing. 


A review carried out by Liu et al. presents the biosimilar monoclonal antibodies market and development status as well as approval process in China and  analyses the patents in this field [1]. 

To do so, the review highlights on a summary of the patents related to biosimilar mAbs in China and their advantages, gives an overview of Chinese biosimilar monoclonal antibody market and development and assess patents that improve the prescription of preparations account for the majority.

Since the first copy biological Rituximab injection by Henlius was launched in 2019, 142 biosimilar mAbs involved 16 targets have been researched and developed in China, and 10 of them have been launched, see Table 1. Adalimumab and bevacizumab are the hotspots in the Chinese biosimilar market, while mAbs with new targets show less competition.

Table 1: R & D projects of different biosimilars conducted in China

GW 4950G 0133G Table 1

The 10 biosimilar mAbs launched in China are Avastin (bevacizumab) x 3, Herceptin (trastuzumab) x 1, Humira (adalimumab) x 4, and MabThera (rituximab) x 2. China has over 60 pharmaceutical companies involved in the development of biosimilar products.

The following series of two articles will provide a summary of the representative companies for biosimilar products and the patents of biosimilar mAbs in China.

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1. Liu J-W, Yang Y-H, Wu N, et al. Biosimilar monoclonal antibodies in China: a patent review, bioengineered. 2022;13(6):14503-18. doi:10.1080/21655979.2022.2090206 

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