Biogen Receives Positive CHMP Opinion for TOFIDENCE (tocilizumab), a Biosimilar Referencing ROACTEMRA
Biogen Inc. (Nasdaq: BIIB) has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for TOFIDENCE (tocilizumab), a biosimilar monoclonal antibody referencing ROACTEMRA. The intravenous formulation of TOFIDENCE has been recommended for approval for the treatment of moderate to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis and COVID-19.
The CHMP’s positive opinion will now be referred to the European Commission (EC), which will decide whether to grant marketing authorization for TOFIDENCE. If a marketing authorization is granted by the EC, TOFIDENCE will be an addition to the existing biosimilars portfolio of three widely prescribed anti-TNF biosimilars commercialized by Biogen in Europe: BENEPALI (etanercept), IMRALDI (adalimumab) and FLIXABI (infliximab), offering an extension to the cost-effective treatment options with an additional mechanism of action.
“The positive CHMP recommendation for TOFIDENCE marks another positive step toward helping more people with inflammatory and immune-mediated conditions gain access to leading therapies,” said Ian Henshaw, Global Head of Biosimilars at Biogen. “Positive CHMP recommendation for TOFIDENCE is testament to our continuing efforts to develop and deliver high-quality and proven biologic medicines to more patients, healthcare providers and healthcare systems in Europe.”
This positive CHMP opinion on TOFIDENCE was 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 equivalence 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, TOFIDENCE, developed by Bio-Thera, is to be commercialized by Biogen in the European Union. 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 inteleukin-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 had an inadequate response to, or who were intolerant to, one or more Disease-Modifying Anti-Rheumatic Drug (DMARD) or tumor necrosis factor (TNF) antagonist.
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.
Source: Biogen
