- TOFIDENCE is Bio-Thera’s first product approved by USFDA.
- 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
GUANGZHOU, China I October 8, 2023 I 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.
TOFIDENCE is Bio-Thera’s first product approved by USFDA
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.
About TOFIDENCE (tocilizumab)
TOFIDENCE (tocilizumab), is a treatment developed as a biosimilar to the reference product ACTEMRA. TOFIDENCE is indicated for the treatment of moderate to severe rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis.
Indications
Rheumatoid Arthritis (RA)
Adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs).
Polyarticular Juvenile Idiopathic Arthritis (PJIA)
Patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis.
Systemic Juvenile Idiopathic Arthritis (SJIA)
Patients 2 years of age and older with active systemic juvenile idiopathic arthritis.
For additional Important Safety Information on TOFIDENCE (tocilizumab-bavi), see full Prescribing Information.
About Bio-Thera Solutions
Bio-Thera Solutions, Ltd., a leading innovative, global biopharmaceutical company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular, eye diseases, and other severe unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases. 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. For more information, please visit www.bio-thera.com/en/or follow us on LinkedIn, X (@bio_thera_sol) and WeChat (Bio-Thera).
- TOFIDENCE™ is a trademark of Biogen, Inc.
- QLETLI® is a registered trademark of Bio-Thera Solutions, Ltd.
- POBEVCY® is a registered trademark of Bio-Thera Solutions, Ltd.
SOURCE: Bio-Thera Solutions
Post Views: 280
- TOFIDENCE is Bio-Thera’s first product approved by USFDA.
- 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
GUANGZHOU, China I October 8, 2023 I 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.
TOFIDENCE is Bio-Thera’s first product approved by USFDA
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.
About TOFIDENCE (tocilizumab)
TOFIDENCE (tocilizumab), is a treatment developed as a biosimilar to the reference product ACTEMRA. TOFIDENCE is indicated for the treatment of moderate to severe rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis.
Indications
Rheumatoid Arthritis (RA)
Adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs).
Polyarticular Juvenile Idiopathic Arthritis (PJIA)
Patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis.
Systemic Juvenile Idiopathic Arthritis (SJIA)
Patients 2 years of age and older with active systemic juvenile idiopathic arthritis.
For additional Important Safety Information on TOFIDENCE (tocilizumab-bavi), see full Prescribing Information.
About Bio-Thera Solutions
Bio-Thera Solutions, Ltd., a leading innovative, global biopharmaceutical company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular, eye diseases, and other severe unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases. 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. For more information, please visit www.bio-thera.com/en/or follow us on LinkedIn, X (@bio_thera_sol) and WeChat (Bio-Thera).
- TOFIDENCE™ is a trademark of Biogen, Inc.
- QLETLI® is a registered trademark of Bio-Thera Solutions, Ltd.
- POBEVCY® is a registered trademark of Bio-Thera Solutions, Ltd.
SOURCE: Bio-Thera Solutions
Post Views: 280
