China approves new formulation of etanercept copy biological Yisaipu

Biosimilars/News | Posted 20/09/2019 post-comment0 Post your comment

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), has approved Yisaipu, an etanercept copy biological as a pre-filled syringe.

X-ray1 MD001877 V13E03

Etanercept is a biological drug that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF); a soluble inflammatory cytokine. Etanercept is indicated for the treatment of rheumatoid, juvenile rheumatoid and psoriatic arthritis, plaque psoriasis and ankylosing spondylitis.

Yisaipu was developed by Sunshine Guojian Pharmaceutical, a subsidiary of 3SBio, and was originally approved in China in 2005 [1] and was launched as powder for injection in 2006. In 2017, it was included in the National Reimbursement Drug List as a Class B Drug.

This application for approval for the new pre-filled aqueous injection solution formulation of Yisaipu was submitted to the NMPA in July 2019. The copy biological has been approved for the treatment of ankylosing spondylitis, moderate and severe active rheumatoid arthritis, and moderate to severe plaque psoriasis. Because of lack of adherence to treatment may be a cause for repeated disease onset, this new formulation is expected to boost the quality of life and treatment compliance for patients.

According to Dr Lou Jing, Chairman and Chief Executive Officer of 3SBio, this pre-filled syringe formulation of Yisaipu is ‘the first of its kind to be sold in China, for patients to self-administer at home, and will be available in more dosages than what is currently sold’. He added that ‘3SBio will continue to focus on the biopharmaceutical field and is committed to exploring and developing more therapeutic biological agents in different dosage forms, so as to meet different medical needs and provide patients with more choices’.

Related article
China approves rituximab copy biological

1. GaBI Online - Generics and Biosimilars Initiative. Copy biologicals approved in China []. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Sep 20]. Available from:

Permission granted to reproduce for personal and non-commercial 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.

Copyright – Unless otherwise stated all contents of this website are © 2019 Pro Pharma Communications International. All Rights Reserved.

Source: Ankylosing Sondilytis News, 3SBio

comment icon Comments (0)
Post your comment
Related content
EC approval of first ustekinumab biosimilar Uzpruvo
Biosimilars/News Posted 16/01/2024
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