Copy biologicals approved in China

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Copy biologicals approved in China

Biosimilares/General | Posted 15/03/2019 0 Post your comment

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 One copy biological Saiputing (trastuzumab) was withdrawn.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. *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

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
Chinese guidelines for copy biologicals

References
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

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Source: NMPA