BAT1806 is the world’s first approved biosimilar toActemra®. ChinaNational Medical Products Administration(NMPA) has approved BAT1806, abiosimilar of Actemra® (tocilizumab), in China. BAT1806 is a recombinant humanized monoclonalantibody targeting interleukin-6 receptor (IL-6R), which specifically binds tosoluble and membrane-bound IL-6 receptors (sIL-6R and mIL-6R) and inhibitssignaling mediated by sIL-6R or mIL-6R. The marketing authorization applicationfor BAT1806/BIIB800 has been accepted by EMA and FDA. BAT1806 is the first tocilizumabbiosimilar approved by the NMPA or any other regulatory agency around the worldandhas been approved for the treatment of rheumatoid arthritis (RA), systemicjuvenile idiopathic arthritis (sJIA), and cytokine release syndrome (CRS). BAT1806 isBio-TheraSolutions’third biosimilar toreceive regulatory approval by the NMPA.
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