• 04 Oct 2023
• Admin
• News Article

Biogens Tofidence, a biosimilar referencing Actemra receives US FDA approval to treat rheumatoid arthritis, PJIA & SJIA

Biogen Inc. announced that the US 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 decade. Since biosimilar entry in the US, medicines with biosimilar competition have experienced greater patient adoption equaling more than 150 million days of patient therapy.“The approval of Tofidence in the US 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 US.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.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.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.