- TOFIDENCE (BIIB800) becomes the first tocilizumab biosimilar to gain FDA approval in the United States
- FDA approval is based on a robust analytical, non-clinical and clinical data package comparing TOFIDENCE to the reference product ACTEMRA
CAMBRIDGE, MA, USA I September 29, 2023 I Biogen Inc. (Nasdaq: BIIB) announced that the U.S. Food and Drug Administration (FDA) has approved 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 is the first tocilizumab biosimilar approved in the United States. Biosimilars are biologic products that have been demonstrated to have equivalent efficacy and comparable safety as the approved reference product, with the advantage that they may offer cost savings and promote expanded and sustainable access to therapies. Spending on therapies for autoimmune diseases has consistently increased by 10%–25% each year over the past decade1. Since biosimilar entry in the US, medicines with biosimilar competition have experienced greater patient adoption equaling more than 150 million days of patient therapy1.
“The approval of TOFIDENCE in the U.S. marks another positive step toward helping more people with chronic autoimmune conditions gain access to leading therapies,” said Ian Henshaw, Global Head of Biosimilars at Biogen. “With the increasing numbers of approved biosimilars, we expect increased savings and sustainability for healthcare systems and an increase in physician choice and patient access to biologics.”
Biogen and Bio-Thera entered into a commercialization and license agreement for TOFIDENCE (BAT1806/BIIB800) in April 2021. Developed by Bio-Thera, TOFIDENCE will be commercialized by Biogen in the United States. Under the agreement, Biogen has exclusive regulatory, manufacturing, and commercial rights to TOFIDENCE in all countries excluding China (including Hong Kong, Macau and Taiwan). Biogen is currently evaluating the potential launch timeline for TOFIDENCE in the U.S.
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 moderately to severely active 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 Biogen
Founded in 1978, Biogen is a leading global biotechnology company that has pioneered multiple breakthrough innovations including a broad portfolio of medicines to treat multiple sclerosis, the first approved treatment for spinal muscular atrophy, and two co-developed treatments to address a defining pathology of Alzheimer’s disease. Biogen is advancing a pipeline of potential novel therapies across neurology, neuropsychiatry, specialized immunology and rare diseases and remains acutely focused on its purpose of serving humanity through science while advancing a healthier, more sustainable and equitable world.
We routinely post information that may be important to investors on our website at www.biogen.com. Follow us on social media – X, LinkedIn, Facebook, YouTube.
References:
- Association for Accessible Medicines. The U.S. Generic & Biosimilars Medicines Savings Report, September 2022. https://accessiblemeds.org/sites/default/files/2022-09/AAM-2022-Generic-Biosimilar-Medicines-Savings-Report.pdf Accessed August 2023.
SOURCE: Biogen
Post Views: 99
- TOFIDENCE (BIIB800) becomes the first tocilizumab biosimilar to gain FDA approval in the United States
- FDA approval is based on a robust analytical, non-clinical and clinical data package comparing TOFIDENCE to the reference product ACTEMRA
CAMBRIDGE, MA, USA I September 29, 2023 I Biogen Inc. (Nasdaq: BIIB) announced that the U.S. Food and Drug Administration (FDA) has approved 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 is the first tocilizumab biosimilar approved in the United States. Biosimilars are biologic products that have been demonstrated to have equivalent efficacy and comparable safety as the approved reference product, with the advantage that they may offer cost savings and promote expanded and sustainable access to therapies. Spending on therapies for autoimmune diseases has consistently increased by 10%–25% each year over the past decade1. Since biosimilar entry in the US, medicines with biosimilar competition have experienced greater patient adoption equaling more than 150 million days of patient therapy1.
“The approval of TOFIDENCE in the U.S. marks another positive step toward helping more people with chronic autoimmune conditions gain access to leading therapies,” said Ian Henshaw, Global Head of Biosimilars at Biogen. “With the increasing numbers of approved biosimilars, we expect increased savings and sustainability for healthcare systems and an increase in physician choice and patient access to biologics.”
Biogen and Bio-Thera entered into a commercialization and license agreement for TOFIDENCE (BAT1806/BIIB800) in April 2021. Developed by Bio-Thera, TOFIDENCE will be commercialized by Biogen in the United States. Under the agreement, Biogen has exclusive regulatory, manufacturing, and commercial rights to TOFIDENCE in all countries excluding China (including Hong Kong, Macau and Taiwan). Biogen is currently evaluating the potential launch timeline for TOFIDENCE in the U.S.
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 moderately to severely active 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 Biogen
Founded in 1978, Biogen is a leading global biotechnology company that has pioneered multiple breakthrough innovations including a broad portfolio of medicines to treat multiple sclerosis, the first approved treatment for spinal muscular atrophy, and two co-developed treatments to address a defining pathology of Alzheimer’s disease. Biogen is advancing a pipeline of potential novel therapies across neurology, neuropsychiatry, specialized immunology and rare diseases and remains acutely focused on its purpose of serving humanity through science while advancing a healthier, more sustainable and equitable world.
We routinely post information that may be important to investors on our website at www.biogen.com. Follow us on social media – X, LinkedIn, Facebook, YouTube.
References:
- Association for Accessible Medicines. The U.S. Generic & Biosimilars Medicines Savings Report, September 2022. https://accessiblemeds.org/sites/default/files/2022-09/AAM-2022-Generic-Biosimilar-Medicines-Savings-Report.pdf Accessed August 2023.
SOURCE: Biogen
Post Views: 99
