China has approved many more copy biologicals in the last three years. A move which, according to Pharmaceutical Technology, is thought could be due to the introduction of new guidelines for the products.
In China, the regulatory body for the approval of medicines, including biologicals, is the National Medical Products Administration (NMPA, 国家药品监督管理局), formerly the China Food and Drug Administration (CFDA: simplified Chinese: 国家食品药品监督管理局).
On 28 February 2015, the NMPA published finalized technical guidance for the development and evaluation of copy biologicals . This came 10 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.
The new regulatory pathway introduced in China created standardized regulations for the development and evaluation of copy biologicals, clarifying their definition 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 R & D on biologicals. This, alongside the increasing reimbursement of biologicals, is, according to Pharmaceutical Technology, helping to drive the growth of copy biologicals in China.
Hanlikon (HLX01) was China’s first copy biological to be approved using the new pathway in February 2019 . According to the NMPA, Henlius Biotech’s Hanlikon was ‘the first product in China to be researched and produced according to the copy biological drug route with rituximab as a reference drug’. The application included comprehensive data on quality similarity studies, non-clinical similarity studies and clinical comparison studies to obtain data on the safety and efficacy of the product.
This approval was followed by three more copy biologicals in 2019, seven in 2020 and two so far in 2021, which means that there are now 20 copy biologicals approved in China . 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 NMPA, as well as approximately 100 more in the pipeline.
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 non-originator biologicals approved only outside of Europe might not have been authorized if they had been subjected to the strict regulatory processes required for approval of biosimilars in the EU.
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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. China approves rituximab copy biological [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Oct 8]. Available from: www.gabionline.net/biosimilars/news/China-approves-rituximab-copy-biological
3. GaBI Online - Generics and Biosimilars Initiative. Copy biologicals approved in China [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Oct 8]. Available from: www.gabionline.net/biosimilars/general/copy-biologicals-approved-in-china
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