According to law firm Hogan Lovells, between 2013 and 2017, new drug applications (NDAs) for biologicals approved by China’s drug regulator, the National Medical Products Administration (NMPA), increased from 6 to 29 and the number of investigational new drug (IND) applications for biologicals (allow trials to be carried out in the country) soared from 78 to 227 (with oncology candidates accounting for 42% of this total).

The approval of Shanghai Henlius Biotech’s rituximab copy biological, Hanlikon (HLX01), in February 2019 marked the first product approved in China following the NMPA new guidelines for such products introduced in 2015 [1]. Prior to these guidelines, copy biologicals, such as Yisaipu (etanercept) which was approved back in 2005, were approved on a case-by-case basis.

Since the launch of Hanlikon, copy biologicals of adalimumab, bevacizumab and trastuzumab have also launched in China. As of 25 March 2021, there are now 12 copy biologicals approved by the NMPA for use in the country [1].

The pipeline of copy biologicals in phase I or III in the country is also believed to be quite extensive. In fact, China currently has the biggest biosimilars pipeline compared to any other country, with almost 40 new copy biologicals expected to enter the market in the near future. For bevacizumab, for example, there are believed to be at least nine Chinese companies carrying out clinical trials for copy biologicals.

This extensive pipeline is made possible by the significant investments in research and development (R & D) that have been carried out by Chinese manufacturers over the past five to eight years. For instance, Innovent disclosed that its R & D expenses surged from RMB 385 million in 2016 to RMB 612 million in 2017, and to a whopping RMB 1.2 billion in 2018. Over the past seven and a half years, Innovent has developed a pipeline of 20 drug candidates, including three copy biologicals approved in China. Byvasda (bevacizumab) was approved by the NMPA in June 2020, Halpryza (rituximab) in October 2020 and Sulinno (adalimumab) in September 2020 [2].

Editor’s comment
European Medicines Agency regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product but they are not universally accepted by regulatory bodies outside of the European Union (EU). It should be noted that ‘copy biologicals’ approved in China might not have been authorized if they had been subjected to the strict regulatory processes required for approval of biosimilars in the EU.

Related articles
Improved regulation favouring copy biologicals in China

Patent expiries may drive development of copy biologicals in China

Cancer driving the need for copy biologicals in China

The state of play for copy biologicals in China

References
1. GaBI Online - Generics and Biosimilars Initiative. Chinese guidelines for copy biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 16]. Available from: www.gabionline.net/Guidelines/Chinese-guidelines-for-copy-biologicals 
2. GaBI Online - Generics and Biosimilars Initiative. Copy biologicals approved in China [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 16]. Available from: www.gabionline.net/Biosimilars/General/Copy-biologicals-approved-in-China

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