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Review
. 2022 Jun;13(6):14503-14518.
doi: 10.1080/21655979.2022.2090206.

Biosimilar monoclonal antibodies in China: A patent review

Jia-Wei Liu  1   2 , Yu-Huan Yang  1   2 , Nan Wu  1 , Ji-Fu Wei  1   3
Affiliations
Review

Biosimilar monoclonal antibodies in China: A patent review

Jia-Wei Liu et al. Bioengineered. 2022 Jun.

Abstract

Biosimilars play an important role in reducing the burden on patients and increasing the market competition. Biosimilar monoclonal antibodies are currently one of the hotspots of research and development in China with policies support. With the continuous improvement of policies, the enthusiasm for the research and development of biosimilars has increased year by year. The policy requirements in different periods have different degrees of impact on the patent applications of pharmaceutical companies. This review introduces the biosimilar monoclonal antibodies market status and approval process in China, analyzes the patents in this field, and helps pharmaceutical companies protect their intellectual property rights.

Keywords: Biosimilar; Chinese patent; autoimmune disease; cancer; monoclonal antibody.

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Conflict of interest statement

No potential conflict of interest was reported by the author(s).

Figures

None
Graphical abstract
Figure 1.
Figure 1.
Numbers of the research and development of different biosimilars in China. Adalimumab and bevacizumab are the hotspots in the Chinese biosimilar market, while mAbs with new targets show less competitions.
Figure 2.
Figure 2.
The developing process of the reference and biosimilar products. The elements of their processes are similar, both containing pharmaceutical studies, non-clinical studies (animal studies), and clinical studies. However, biosimilar products pay more attention on comparative studies and their indications can be extrapolated.
Figure 3.
Figure 3.
Outline of biosimilar patents in China. a The classification of biosimilar patents and the distribution. b Different targets of biosimilars and the patents of each target. c Trend analysis for Chinese patents on mAb biosimilars.
See this image and copyright information in PMC

References

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