Bio-Thera Solutions, Ltd. announced that its partner Biogen recently received notification from the United States Food and Drug Administration (FDA) on the approval of TOFIDENCE (tocilizumab-bavi) intravenous formulation, a biosimilar monoclonal antibody referencing ACTEMRA. The TOFIDENCE intravenous formulation is approved for the treatment of moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis. TOFIDENCE (BAT1806 /BIIB800) is Bio-Thera's first FDA approved product in the United States, and the first biosimilar developed and manufactured by a Chinese pharmaceutical company approved in the United States.

TOFIDENCE was based on a comprehensive analytical, non-clinical and clinical data package submitted by Biogen to the FDA in Sept 2022. Extensive analytical characterization of the structural, physiological, and biological properties of TOFIDENCE was conducted and supports biosimilarity with the reference product. As a leader in next generation antibody discovery and engineering, the company has advanced multiple candidates into late-stage development, including three approved products, QLETLI®?, POBEVCY®?

and BAT1806 in China. In addition, the company has more than 20 promising candidates in clinical trials, focusing on immuno-oncology in the post-PD-1 era and targeted therapies such as ADCs.