China released finalized technical guidance for the development and evaluation of copy biologicals in February 2015 . To date, China’s drug regulator, the National Medical Products Administration (NMPA), has approved 12 copy biologicals for use in China .
Although four copy biologicals were approved before the technical guidance was implemented, the first copy biological approved in China following the requirements of the 2015 guidance was the rituximab copy biological Hanlikon (HLX01). Hanlikon was developed by Shanghai Henlius Biopharmaceutical (Henlius) and approved in 2019 . This compares to the first biosimilar in Europe, Sandoz’s Omnitrope (somatropin), which was approved in 2006 , and the first biosimilar in the US, Zarxio (filgrastim-sndz), which was approved in 2015 .
Henlius had its trastuzumab biosimilar Zercepac (HLX02) approved in Europe in July 2020 as the first China-made biosimilar to receive approval in Europe .
China’s late arrival on the global scene could be an advantage, as both regulators and industry players benefit from the experience and lessons learned by their European and American peers. In fact, according to Hogan Lovells China’s timing could be impeccable for the following reasons:
- the need for innovative therapies in China – particularly in areas such as oncology – has never been greater
- a large number of blockbuster biologicals are coming off patent between 2019 and 2025
- the Chinese government is looking for alternatives to curb rising expenses from branded/originator drugs and is establishing a robust regulatory framework
- Chinese manufacturers are closing the gap with global peers in terms of R & D expertise and investments.
The combination of these factors is expected to propel the Chinese copy biological market to RMB 33 billion (Euros 4.25 billion) by 2025.
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.
Investment increasing pipeline of copy biologicals in China
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
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1. Derbyshire M. Regulation of copy biologicals in China. Generics and Biosimilars Initiative Journal (GaBI Journal). 2018;7(2):75-6. doi:10.5639/gabij.2018.0702.015
2. GaBI Online - Generics and Biosimilars Initiative. Copy biologicals approved in China [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 19]. Available from: www.gabionline.net/Biosimilars/General/Copy-biologicals-approved-in-China
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 19]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 19]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
5. GaBI Online - Generics and Biosimilars Initiative. EC approval for trastuzumab biosimilar Zercepac [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 19]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-trastuzumab-biosimilar-Zercepac
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