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Copy biologicals approved in China Posted 15/03/2019

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 five 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 One copy biological Saiputing (trastuzumab) was withdrawn.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 four 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

Hanlikon

rituximab

Non-Hodgkin’s lymphoma

22 Feb 2019

Shanghai Fuhong Hanlin Bio-Pharmaceutical

Qiangke

etanercept

Axial spondyloarthritis

Psoriatic arthritis

Plaque psoriasis

Rheumatoid arthritis

2011

Shanghai Celgen Biopharma

Saiputing

trastuzumab

Early breast cancer

Metastatic breast cancer

Metastatic gastric cancer

2014 later withdrawn

Shanghai CP Guojian Pharmaceutical

Yisaipu

etanercept

Axial spondyloarthritis

Psoriatic arthritis

Plaque psoriasis

Rheumatoid arthritis

2005

Shanghai CP Guojian Pharmaceutical

*Data collected on 15 March 2019; **Therapeutic area taken from company or National Medical Products Administration information, from originator product information on the European Medicines Agency (EMA)  website.

Editor’s comment
It should be noted that copy biologicals approved in China might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the European Union. The EMA (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.

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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