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Copy biologicals approved in China Posted 15/03/2019
Last update: 2 April 2021 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).
On 29 October 2014, the Chinese Center for Drug Evaluation (CDE), which was part of CFDA, published draft copy biologicals guidance [1]. A finalized technical guidance for the development and evaluation of copy biologicals was released on 28 February 2015 [2]. To date, the NMPA has approved 14 copy biologicals, within the product classes of monoclonal antibody and tumour necrosis factor (TNF)-inhibitor, see Table 1, for use in China. One copy biological Saiputing (trastuzumab) was withdrawn. This leaves a total of 13 copy biologicals approved for use in China. Table 1: NMPA approved copy biologicals* Product name Active substance Therapeutic area** Authorization date Manufacturer/ Company name AnBaiNuo etanercept Axial spondyloarthritis Psoriatic arthritis Plaque psoriasis Rheumatoid arthritis 2015 Hisun Pharmaceuticals Ankada bevacizumab Advanced, metastatic or recurrent NSCLC Metastatic colorectal cancer 9 Dec 2019 Qilu Pharmaceutical Byvasda bevacizumab Advanced NSCLC Metastatic colorectal cancer Recurrent glioblastoma 17 Jun 2020 Innovent Biologics GB242 infliximab Ankylosing spondylitis Crohn’s disease Psoriatic arthritis Psoriasis Rheumatoid arthritis Ulcerative colitis Under NMPA review 4 Nov 2020 Genor Biopharma Halpryza rituximab Diffuse large B-cell lymphoma Follicular lymphoma Chronic lymphocytic leukaemia 9 Oct 2020 Innovent Biologics/ Eli Lilly Handa Yuan (HLX03) adalimumab Ankylosing spondylitis Crohn’s disease Juvenile idiopathic arthritis Psoriasis Psoriatic arthritis Rheumatoid arthritis Ulcerative colitis 7 Dec 2020 Shanghai Henlius Biotech Hanlikon (HLX01) rituximab Non-Hodgkin’s lymphoma 22 Feb 2019 Shanghai Fuhong Hanlin Bio-Pharmaceutical (Henlius) Han Quyou (HLX02) trastuzumab HER2+ early breast cancer HER2+ metastatic breast cancer HER2+ metastatic gastric cancer 14 Aug 2020 Shanghai Henlius Biotech HS 016 adalimumab Ankylosing spondylitis Crohn’s disease Juvenile idiopathic arthritis Psoriasis Psoriatic arthritis Rheumatoid arthritis Ulcerative colitis 2019 Zhejiang Hisun Pharmaceuticals Qiangke etanercept Axial spondyloarthritis Psoriatic arthritis Plaque psoriasis Rheumatoid arthritis 2011 Shanghai Celgen Biopharma Qletli adalimumab Ankylosing spondylitis Psoriasis Rheumatoid arthritis 7 Nov 2019 Bio-Thera Solutions Saiputing trastuzumab Early breast cancer Metastatic breast cancer Metastatic gastric cancer 2014 later withdrawn Shanghai CP Guojian Pharmaceutical Sulinno adalimumab Ankylosing spondylitis Paediatric plaque psoriasis Polyarticular juvenile idiopathic arthritis Psoriasis Rheumatoid arthritis Uveitis 2 Sep 2020 Innovent Biologics Yisaipu etanercept Axial spondyloarthritis Psoriatic arthritis Plaque psoriasis Rheumatoid arthritis 2005 Shanghai CP Guojian Pharmaceutical
*Data updated on 2 April 2021.
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**Therapeutic area taken from company information, National Medical Products Administration information or from originator product information on the European Medicines Agency (EMA) website.
HER2+: human epidermal growth factor receptor 2 positive; NMPA: National Medical Products Administration; NSCLC: non-small cell lung cancer
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.
Chinese guidelines for copy biologicals
1. GaBI Online - Generics and Biosimilars Initiative. China to release biosimilars guidelines [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Mar 15]. Available from: www.gabionline.net/Guidelines/China-to-release-biosimilars-guidelines
2. 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
Source: NMPA
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