Bio-Thera Solutions has received approval for the biosimilar of Actemra (tocilizumab), BAT1806, from the National Medical Products Administration (NMPA) of China.
The tocilizumab injection, BAT1806 is a recombinant humanised monoclonal antibody which has been developed to target interleukin-6 receptor (IL-6R).
IL-6R specially binds to soluble and membrane-bound IL-6 receptors (sIL-6R and mIL-6R) and inhibits sIL-6R or mIL-6R-mediated signalling.
BAT1806 is claimed to be the first tocilizumab biosimilar to receive NMPA approval or any other regulatory approval across the globe.
It has been approved to treat cytokine release syndrome (CRS), rheumatoid arthritis (RA), and systemic juvenile idiopathic arthritis (sJIA).
The FDA and EMA have accepted the marketing authorisation application for BAT1806/BIIB800.
Bio-Thera Solution founder and CEO Dr Shengfeng Li said: “We are delighted that BAT1806 has been approved as the world’s first tocilizumab biosimilar.
“This is a very important step for Bio-Thera in the field of rheumatology, and it is more important to patients as its approval provides a new treatment option to many patients with autoimmune conditions.
“China is currently facing an unprecedented spread of the Covid-19 infections, and BAT1806 provides a treatment option to many hospitalized Covid-19 patients with severe lung conditions”.
The US has approved the company’s reference product, Actemra, to treat RA, systemic sclerosis-associated interstitial lung disease (SSc-ILD), cytokine release syndrome (CRS), Covid-19, giant cell arthritis (GCA), systemic juvenile idiopathic arthritis (sJIA), and polyarticular juvenile idiopathic arthritis (pJIA).
BAT1806 was found to be highly similar to the reference drug in terms of efficacy, safety, and quality, in complete non-clinical similarity, analytical similarity, and clinical studies.