- TOFIDENCE™ complements existing portfolio of immunology biosimilars commercialized by Biogen
CAMBRIDGE, MA, USA I June 24, 2024 I Biogen Inc. (Nasdaq: BIIB) announced that the European Commission (EC) has granted approval for TOFIDENCETM, a biosimilar monoclonal antibody referencing ROACTEMRA®1. The intravenous formulation of TOFIDENCE has been granted marketing authorization by the EC for the treatment of moderate to severe active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis and COVID-19.
“The approval of TOFIDENCE offers European patients with several inflammatory and immune-mediated inflammatory diseases access to an additional affordable biologic treatment option with comparable safety and efficacy to the approved reference product,” said Ian Henshaw, Global Head of Biosimilars at Biogen. “By adding TOFIDENCE to our growing biosimilars portfolio, we can provide greater choice to physicians and patients whilst offering the potential for significant cost-savings across healthcare systems in Europe.”
The EC approval of TOFIDENCE is based on the totality of evidence comprising a comprehensive analytical, non-clinical and clinical data package. Extensive analytical characterization of the structural, physicochemical, and biological properties of TOFIDENCE was conducted and supports comparability with the reference biologic product. Additionally, a randomized double-blind, single-dose, three-arm, parallel group Phase 1 study compared the pharmacokinetics, safety and immunogenicity of TOFIDENCE with both the EU and US reference tocilizumab in healthy volunteers, while a randomized, double-blind, multi-dose, three-arm, parallel group Phase 3 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.
Biogen and Bio-Thera entered into a commercialization and licensing agreement for TOFIDENCE (BAT1806/BIIB800) in April 2021. Under the agreement, Biogen has exclusive regulatory, manufacturing, and commercial rights to TOFIDENCE in all countries excluding China (including Hong Kong, Macau and Taiwan).
About TOFIDENCE (tocilizumab)
TOFIDENCE (tocilizumab), an interleukin-6 receptor antagonist, is a treatment developed as a biosimilar to the reference product ROACTEMRA. TOFIDENCE is indicated for the treatment of moderate to severe active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis and COVID-19.
Indications
Rheumatoid Arthritis (RA)
Adult patients with moderately to severely active rheumatoid arthritis who have an inadequate response to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumor necrosis factor (TNF) antagonists.
Adult patients with severe, active and progressive RA not previously treated with methotrexate (MTX).
In these patients, TOFIDENCE can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.
Polyarticular Juvenile Idiopathic Arthritis (PJIA)
Patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis who have responded inadequately to previous therapy with MTX. In these patients, TOFIDENCE™ can be given as monotherapy in case of intolerance to MTX or where continued treatment with methotrexate (MTX) is inappropriate.
Systemic Juvenile Idiopathic Arthritis (SJIA)
Patients 2 years of age and older with active systemic juvenile idiopathic arthritis who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids. TOFIDENCE™ can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.
Coronavirus disease 2019 (Covid-19)
Adult patients who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.
About Biogen
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients’ lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth.
We routinely post information that may be important to investors on our website at www.biogen.com. Follow us on social media – Facebook, LinkedIn, X, YouTube.
SOURCE: Biogen
Post Views: 1,397
- TOFIDENCE™ complements existing portfolio of immunology biosimilars commercialized by Biogen
CAMBRIDGE, MA, USA I June 24, 2024 I Biogen Inc. (Nasdaq: BIIB) announced that the European Commission (EC) has granted approval for TOFIDENCETM, a biosimilar monoclonal antibody referencing ROACTEMRA®1. The intravenous formulation of TOFIDENCE has been granted marketing authorization by the EC for the treatment of moderate to severe active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis and COVID-19.
“The approval of TOFIDENCE offers European patients with several inflammatory and immune-mediated inflammatory diseases access to an additional affordable biologic treatment option with comparable safety and efficacy to the approved reference product,” said Ian Henshaw, Global Head of Biosimilars at Biogen. “By adding TOFIDENCE to our growing biosimilars portfolio, we can provide greater choice to physicians and patients whilst offering the potential for significant cost-savings across healthcare systems in Europe.”
The EC approval of TOFIDENCE is based on the totality of evidence comprising a comprehensive analytical, non-clinical and clinical data package. Extensive analytical characterization of the structural, physicochemical, and biological properties of TOFIDENCE was conducted and supports comparability with the reference biologic product. Additionally, a randomized double-blind, single-dose, three-arm, parallel group Phase 1 study compared the pharmacokinetics, safety and immunogenicity of TOFIDENCE with both the EU and US reference tocilizumab in healthy volunteers, while a randomized, double-blind, multi-dose, three-arm, parallel group Phase 3 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.
Biogen and Bio-Thera entered into a commercialization and licensing agreement for TOFIDENCE (BAT1806/BIIB800) in April 2021. Under the agreement, Biogen has exclusive regulatory, manufacturing, and commercial rights to TOFIDENCE in all countries excluding China (including Hong Kong, Macau and Taiwan).
About TOFIDENCE (tocilizumab)
TOFIDENCE (tocilizumab), an interleukin-6 receptor antagonist, is a treatment developed as a biosimilar to the reference product ROACTEMRA. TOFIDENCE is indicated for the treatment of moderate to severe active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis and COVID-19.
Indications
Rheumatoid Arthritis (RA)
Adult patients with moderately to severely active rheumatoid arthritis who have an inadequate response to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumor necrosis factor (TNF) antagonists.
Adult patients with severe, active and progressive RA not previously treated with methotrexate (MTX).
In these patients, TOFIDENCE can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.
Polyarticular Juvenile Idiopathic Arthritis (PJIA)
Patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis who have responded inadequately to previous therapy with MTX. In these patients, TOFIDENCE™ can be given as monotherapy in case of intolerance to MTX or where continued treatment with methotrexate (MTX) is inappropriate.
Systemic Juvenile Idiopathic Arthritis (SJIA)
Patients 2 years of age and older with active systemic juvenile idiopathic arthritis who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids. TOFIDENCE™ can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.
Coronavirus disease 2019 (Covid-19)
Adult patients who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.
About Biogen
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients’ lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth.
We routinely post information that may be important to investors on our website at www.biogen.com. Follow us on social media – Facebook, LinkedIn, X, YouTube.
SOURCE: Biogen
Post Views: 1,397
