China approves tocilizumab copy biological BAT1806

Biosimilares/Novedades | Posted 16/03/2023 post-comment0 Post your comment

In January 2023, Bio-Thera Solutions announced that the China National Medical Products Administration (NMPA) approved BAT1806, a biosimilar of Actemra (tocilizumab), in China. This is the world’s first tocilizumab copy biological/biosimilar to be approved.

Toclizumab Roche V16G29

Tocilizumab is a humanized monoclonal antibody against the interleukin-6 receptor (IL-6R). It is an immunosuppressive drug used mainly for the treatment of rheumatoid arthritis and systemic juvenile idiopathic arthritis, a severe form of arthritis in children. In Japan, tocilizumab is also approved for the treatment of Castleman’s disease, a rare benign tumour of B cells [1].

The originator product, Roche’s Actemra/RoActemra (tocilizumab), was approved by the US Food and Drug Administration (FDA) on 8 January 2010 and on 16 January 2009 by the European Medicines Agency (EMA) [1]. Tocilizumab was approved in Japan for Castleman’s disease in June 2005. Actemra/RoActemra had worldwide sales of CHF 1.4 billion (US$1.4 billion) in 2015.

Bio-Thera announced positive phase III data for BAT1806 in June 2021, demonstrating equivalent efficacy and comparable safety to the originator in patients with moderate-to-severe rheumatoid arthritis [2]. In November 2021, China’s NMPA accepted Bio-Thera’s marketing authorization application for BAT1806 [3].

Bio-Thera stated that BAT1806 is the first tocilizumab biosimilar approved by the NMPA or any other regulatory agency around the world and has been approved for the treatment of rheumatoid arthritis, systemic juvenile idiopathic arthritis and cytokine release syndrome.  BAT1806 is Bio-Thera Solutions’ third biosimilar to receive regulatory approval by the NMPA. 

Bio-Thera is developing several additional biosimilar products for the global market. These include golimumab [4], ustekinumab [5], mepolizumab and secukinumab biosimilars [6].

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1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of tocilizumab []. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Mar 16]. Available from:
2. GaBI Online - Generics and Biosimilars Initiative. Positive phase III results for tocilizumab biosimilar Bat1806 []. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Mar 16]. Available from:
3. GaBI Online - Generics and Biosimilars Initiative. China accepts Bio-Thera’s application for tocilizumab copy biological BAT1806 []. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Mar 16]. Available from:
4. GaBI Online - Generics and Biosimilars Initiative. Clinical trials begin for Bio-Thera’s golimumab copy biological []. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Mar 16]. Available from:
5. GaBI Online - Generics and Biosimilars Initiative. Bio-Thera and Samsung Bioepis start clinical trials for ustekinumab biosimilars []. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Mar 16]. Available from:
6. GaBI Online - Generics and Biosimilars Initiative. Advances for Bio-Thera’s secukinumab and mepolizumab copy biologicals []. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Mar 16]. Available from:

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