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China approves new formulation of etanercept copy biological Yisaipu Posted 20/09/2019

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.

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’.

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

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Source: Ankylosing Sondilytis News, 3SBio

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