TNF copy biological approved in China

Biosimilars/News | Posted 20/05/2011 post-comment1 Post your comment

China-based Simcere Pharmaceutical Group (Simcere) announced on 9 May 2011 that Shanghai Celgen Bio-Pharmaceutical (Shanghai Celgen) has received approval for Qiangke – a copy biological version of etanercept – by the Chinese authorities.

picture18

Simcere owns 35% of Shanghai Celgen. Qiangke is a recombinant human tumour necrosis factor (TNF) receptor-IgG fusion protein for injection. It is used for treatment of ankylosing spondylitis—a type of spondyloarthritis affecting the lower back. It is also indicated for other automimmune diseases such as psoriasis, rheumatoid arthritis and psoriatic arthritis.

Shanghai Celgen is currently preparing for the expected good manufacturing practice inspection by the Chinese State Food and Drug Administration.

Simcere believes that the product holds strong market potential. This is probably not unfounded, since Pfizer/Amgen which produce the originator version of etanercept (Enbrel) posted record sales of US$3,274 million in 2010.

The US patent on Enbrel expires in October 2012, which opens up the market for biosimilars or copy biologicals, such as Shanghai Celgen’s, to bite a chunk out of the massive etanercept pie.

China, one of the largest pharmaceutical markets in the world, has yet to issue biosimilars guidelines, although domestic copy biologicals have been on the market in China for 20 years. Copy biologicals in China therefore have to go through a new drug or generic drug approval process.

Editor’s Comment
The question is whether such copy biologicals approved in China can also meet the stringent requirements for comparability required by the EMA for approval in the EU.

Please feel free to share your thoughts via email or in the comments section below. What are your views on biosimilars approved in other regions of the world? How do you think these biosimilars, or as some call them ‘alternative’ biologicals, compare to those approved in the EU?

Related article

2012’s biggest patent expiries

Permission granted to reproduce for personal and educational use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Source: Pfizer, Simcere

comment icon Comments (1)
Post your comment
Posted 24/09/2011 by Vinay Konaje
Biogenerics - challenges getting into US

Fact is if the Americans are hell bent on fooling themselves by trying to block competition from follow-on biologics, there really is nothing that the rest of the world can or will want to do. Lets see how long the originator companies are able to price their drugs atrociously even in the US. Finally somebody has to pay for it and something will give way.

Related content
EC approves bevacizumab biosimilar Vegzelma
Anaemia 2 V13J18
Biosimilars/News Posted 23/09/2022
EC approves ranibizumab biosimilar Ranivisio
Age-related macular degeneration V15b19
Biosimilars/News Posted 16/09/2022
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010