Strong pipeline, favorable regulatory landscape to drive China biosimilar market, says GlobalData

China has seen a significant surge in biosimilar approvals over the last three years, with 13 new biosimilars approved during 2018–2021. Strong biosimilar pipeline and the latest regulation changes by the National Medical Products Administration (NMPA) are likely to drive China’s biosimilar market to new heights, says GlobalData, a leading data and analytics company.

Prior to 2019, China had no official biosimilars available. The recent surge in biosimilars has helped China become one of the leading biosimilar markets in only three years, overtaking South Korea to reach second place behind Japan, in terms of number of approvals in 2019.

Mr Quentin Horgan, Senior Drugs Database Analyst at GlobalData, comments: “China stimulated its biosimilars market through the implementation of new legislation and regulations by NMPA. In 2015, the NMPA released the first guidelines for an established biosimilar pathway within China.”

This new regulatory pathway created standardized regulations for the development and evaluation of biosimilars, clarifying the definition of biosimilars, and setting standards for preclinical R&D, clinical trials, and manufacturing, making it easier for the development and approval of biosimilars.

Mr Horgan continues: “Additionally, the NMPA has made multiple regulatory changes to reduce the costs and barriers for companies performing biologics R&D. This, alongside the new biosimilar guidelines, is driving Chinese biosimilar approvals leading to remarkable growth.”

In February 2019, China’s first official biosimilar, the rituximab biosimilar HLX01, was approved. It is developed by Shanghai Henlius Biopharmaceutical for the treatment of non-Hodgkin’s lymphoma (NHL).

Three more biosimilars were approved in China in 2019, and seven biosimilars were approved in 2020, an increase of 75% between 2019 and 2020. There have already been two biosimilar approvals in China in H1 2021. A bevacizumab biosimilar by Luye Pharma Group Ltd was approved in May 2021 for non-small cell lung cancer, and an infliximab biosimilar by Mabpharm Ltd was approved in July 2021 for ankylosing spondylitis (Bekhterev’s Disease).

Mr Horgan concludes: “The surge in Chinese biosimilars looks set to continue into the future, with 11 biosimilar drugs currently in pre-registration and awaiting approval by the NMPA, as well as approximately 100 biosimilars in the pipeline.”

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