NMPA approves BAT 1806 in China, a biosimilar to Actemra.- Bio-Thera Solutions.
Bio-Thera Solutions, Ltd. announced that the China National Medical Products Administration (NMPA) has approved BAT 1806, a biosimilar of Actemra (tocilizumab), in China. BAT 1806 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 (RA), systemic juvenile idiopathic arthritis (sJIA), and cytokine release syndrome (CRS).
BAT 1806 is Bio-Thera Solutions’ third biosimilar to receive regulatory approval by the NMPA.
Dr. Shengfeng Li, Founder and CEO of Bio-Thera Solution said, “We are delighted that BAT 1806 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.” Dr. Li continues, “China is currently facing an unprecedented spread of the COVID-19 infections, and BAT 1806 provides a treatment option to many hospitalized COVID-19 patients with severe lung conditions”.