Monday, July 15, 2024

Biosimilar TOFIDENCE™ (tocilizumab) Approved in the European Union, Referencing ROACTEMRA®

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Biosimilar monoclonal antibody TOFIDENCE™, referencing ROACTEMRA®, has been approved by the European Commission (EC), as announced by Biogen Inc. on June 24, 2024, in Cambridge, Mass. The intravenous formulation of TOFIDENCE has been authorized 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 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 while offering the potential for significant cost savings across healthcare systems in Europe.”

Biosimilar Approval: EC Grants Approval for TOFIDENCE Based on Comprehensive Data

The EC approval of TOFIDENCE is based on comprehensive analytical, non-clinical, and clinical data. Extensive analytical characterization of the structural, physicochemical, and biological properties of TOFIDENCE supports its 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.

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 that 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).

Biosimilar

Biosimilar TOFIDENCE (tocilizumab) Approved for Multiple Indications Including Rheumatoid Arthritis and COVID-19

TOFIDENCE (tocilizumab) is an interleukin-6 receptor antagonist developed as a biosimilar to the reference product ROACTEMRA. It is indicated for the treatment of moderate to severe active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19.

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, as well as adult patients with severe, active, and progressive RA not previously treated with methotrexate (MTX), can be given TOFIDENCE as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.

Patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis who have responded inadequately to previous therapy with MTX can be given TOFIDENCE as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.

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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 can be given TOFIDENCE as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.

TOFIDENCE represents a significant addition to Biogen’s portfolio of immunology biosimilars, offering an affordable and effective treatment option for patients with inflammatory and immune-mediated diseases. This approval not only enhances treatment options but also supports the broader healthcare system by providing cost-effective alternatives to existing therapies. With its proven efficacy and safety profile, TOFIDENCE is poised to become a valuable tool in managing various autoimmune conditions in Europe.

Resource: Biogen, June 24, 2024

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