TOFIDENCE is the first monoclonal antibody drug researched, developed, and manufactured by a Chinese pharmaceutical company to receive FDA approval in the United States
TOFIDENCE is the first biosimilar to Actemra approved by USFDA. (Credit: Towfiqu barbhuiya on Unsplash)
Bio-Thera Solutions, Ltd (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of biosimilars and innovative assets, 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.
Tocilizumab-bavi is a monoclonal antibody that binds to interlukin-6 receptors and is used to treat various inflammatory autoimmune conditions, including rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis.
“The approval of TOFIDENCE is a landmark achievement for Bio-Thera as it marks Bio-Thera’s first FDA approval for a product in the United States” said Shengfeng Li, CEO at Bio-Thera. “Bio-Thera is committed to developing biosimilars for patients around the globe and this approval demonstrates that commitment.”
Biogen and Bio-Thera entered into a partnership agreement for TOFIDENCE (BAT1806/BIIB800) in April 2021. Developed by Bio-Thera, TOFIDENCE will be commercialized by Biogen in all countries excluding China (including Hong Kong, Macau and Taiwan).
The FDA approval of 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, physicochemical, and biological properties of TOFIDENCE was conducted and supports biosimilarity with the reference product. Additionally, a randomized double-blind, single-dose, three-arm, parallel phase I study compared the pharmacokinetics, safety and immunogenicity of TOFIDENCE with both the US and EU reference tocilizumab in healthy volunteers, while a randomized, double-blind, multi-dose, three-arm parallel phase III study compared TOFIDENCE with tocilizumab to establish equivalent efficacy and comparable pharmacokinetic, safety and immunogenicity profiles, in subjects with rheumatoid arthritis inadequately controlled by methotrexate. The totality of evidence demonstrated TOFIDENCE is a biosimilar of the reference biologic.
Source: Company Press Release