TOFIDENCE™ (tocilizumab) Biosimilar to ROACTEMRA® Approved in EU

Biogen Inc. has announced that the European Commission (EC) has approved TOFIDENCE™, a biosimilar monoclonal antibody referencing ROACTEMRA®. TOFIDENCE is an intravenous formulation designed for treating various severe inflammatory conditions, including moderate to severe active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19.

Ian Henshaw, Global Head of Biosimilars at Biogen, highlighted the significance of this approval, stating that TOFIDENCE offers European patients an affordable biologic treatment option that matches the safety and efficacy of its reference product. Henshaw emphasized that adding TOFIDENCE to Biogen’s biosimilars portfolio provides more choices for physicians and patients and could lead to substantial cost savings across European healthcare systems.

The EC's approval of TOFIDENCE was based on comprehensive evidence, including detailed analytical, non-clinical, and clinical studies. Extensive characterization of TOFIDENCE's structural, physicochemical, and biological properties demonstrated its comparability with the reference biologic, ROACTEMRA. A Phase 1 study compared the pharmacokinetics, safety, and immunogenicity of TOFIDENCE with EU and US reference tocilizumab in healthy volunteers. Additionally, a Phase 3 study involving subjects with rheumatoid arthritis inadequately controlled by methotrexate confirmed equivalent efficacy and comparable pharmacokinetic, safety, and immunogenicity profiles between TOFIDENCE and tocilizumab. The evidence concluded that TOFIDENCE is a biosimilar to the reference product.

In April 2021, Biogen entered into a commercialization and licensing agreement for TOFIDENCE (BAT1806/BIIB800) with Bio-Thera. This agreement grants Biogen exclusive rights to regulate, manufacture, and commercialize TOFIDENCE in all countries except China, including Hong Kong, Macau, and Taiwan.

TOFIDENCE, which is an interleukin-6 receptor antagonist, is developed as a biosimilar to ROACTEMRA and is intended for treating moderate to severe active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19.

Biogen, founded in 1978, is a leading biotechnology company committed to pioneering innovative science to develop new medicines that transform patients' lives. The company leverages a deep understanding of human biology to advance first-in-class treatments that deliver superior outcomes. Biogen aims to balance bold risks with a return on investment to ensure long-term growth.