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 One copy biological Saiputing (trastuzumab) was withdrawn.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