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July 30, 2021updated 22 Nov 2021 7:43am

Chinese biosimilars surge between 2018 and 2020 due to new NMPA regulations

There has been an increase for China in biosimilar approvals and its biosimilars market will be driven to further growth in the future.

By GlobalData Healthcare

China has seen a significant surge in biosimilar approvals over the last three years, with 13 new biosimilars approved during 2018–2021, bringing the total biosimilars approved in China to 20. With China’s large biosimilar pipeline, this trend looks set to continue into the future.

Currently, China has a large generics market, as approximately 90% of all marketed drugs in China are generics. In comparison, biosimilars only account for 0.002% of all marketed drugs. To date, the biosimilars market in China has been limited, trailing behind other Asia-Pacific (APAC) markets such as Japan and South Korea. Japan currently has 26 approved biosimilars and South Korea has 18 approved biosimilars. Prior to this recent surge, which began in 2019, China had no official biosimilars available on the market.

China stimulated its biosimilars market through the implementation of new legislation and regulations by the Chinese regulatory authority, the National Medical Products Administration (NMPA). In 2015, the NMPA released the first guidelines for an established biosimilar pathway within China, ten years after the EU implemented the first-ever regulatory pathway for biosimilars in 2006 and nearly six years after South Korea and Japan implemented their own frameworks in 2009. This new regulatory pathway created standardised regulations for the development and evaluation of biosimilars, clarifying the definition of biosimilars and setting standards for preclinical R&D, clinical trials and manufacturing. Additionally, the NMPA made multiple regulatory changes to reduce the costs and barriers for companies performing biologics R&D. This, alongside the increasing reimbursement of biologic drugs, is helping to drive biosimilar growth in China. In February 2019, China’s first official biosimilar was approved. The rituximab biosimilar HLX01 was 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, at an increase of 75% between 2019 and 2020. There have been 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). This 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.

This 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 according to a number of approvals. China’s strong biosimilar pipeline and the latest regulation changes by the NMPA are likely to drive China’s biosimilar markets to new heights.

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