In China, the regulatory body for the approval of medicines, including biologicals, is the National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA: simplified Chinese: 国家食品药品监督管理局).

In her presentation, Dr Hao stated that on the one hand, Europe has the most advanced and growing biosimilar market with favourable regulatory and reimbursement policies to accelerate biosimilar approval and uptake, and on the other hand, China is becoming a global powerhouse in copy biological with the world’s No. 1 pipeline and world quality at a cost advantage. From the perspective of healthcare systems, doctors and patients, there is a lower budget impact (achieve cost savings and less budget pressure), a broader access (initiate early biological treatment and improve patient outcomes) and more affordability (pay less for world quality biological treatment) [1].
 
The first China-made biosimilar to receive approval in Europe was Henlius’ trastuzumab biosimilar Zercepac (HLX02), it has been granted marketing authorization by the European Commission (EC) on 20 July 2020 [2].

By October 2021, there are 20 copy biologicals approved in China [3], and according to Pharmaceutical Technology, this increase in Chinese approvals is set to increase with 11 copy biologicals currently in pre-registration and awaiting approval by the National Medical Products Administration (NMPA), as well as approximately 100 more in the pipeline [4]. Investment in research and development for copy biologicals is producing this extensive pipeline of products in China [5].

In the following series of three articles, the pathways for Chinese companies to enter EU markets; the challenges for Chinese companies to bring biosimilars to EU; and considerations of cross-border market expansion for biosimilars will be discussed.

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

Pathways for Chinese pharmaceutical companies to enter EU markets

China approves three bevacizumab copy biologicals

China accepts Bio-Thera’s application for tocilizumab copy biological BAT1806

The future of copy biologicals in China

Generics and Biosimilars Initiative. Access to biosimilars in China, the EU and the US

References
1. International Commercialization of Biosmilars. Focus on Chinese biosimilars entering European markets. PowerPoint presentation Jenny Hao. 9 November 2021, Basel, Switzerland.
2. GaBI Online - Generics and Biosimilars Initiative. EC approval for trastuzumab biosimilar Zercepac [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Apr 22]. Available from: www.gabionline.net/biosimilars/news/EC-approval-for-trastuzumab-biosimilar-Zercepac
3. GaBI Online - Generics and Biosimilars Initiative. Copy biologicals approved in China [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Apr 22]. Available from: www.gabionline.net/biosimilars/general/copy-biologicals-approved-in-china
4. GaBI Online - Generics and Biosimilars Initiative. China approving more copy biologicals since new guidelines introduced [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Apr 22]. Available from: www.gabionline.net/biosimilars/general/china-approving-more-copy-biologicals-since-new-guidelines-introduced
5. GaBI Online - Generics and Biosimilars Initiative. Investment increasing pipeline of copy biologicals in China [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Apr 22]. Available from: www.gabionline.net/reports/Investment-increasing-pipeline-of-copy-biologicals-in-China

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