Copy biologicals approved in China

Biosimilars/General | Posted 15/03/2019 post-comment0 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).

NMPA

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 One copy biological Saiputing (trastuzumab) was withdrawn.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

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