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TOFIDENCE - A biosimilar medicine from Biogen
TOFIDENCE - A biosimilar medicine from Biogen
TOFIDENCE - A biosimilar medicine from Biogen

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TOFIDENCE™ (tocilizumab-bavi) injection, for intravenous use, was the first FDA-approved biosimilar* to Actemra. TOFIDENCE is indicated for adult patients with RA, GCA, and COVID-19, and patients 2 years of age and older with PJIA and SJIA.1,2

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Using TOFIDENCE

TOFIDENCE is administered intravenously, with weight-based dosing and dose monitoring1

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Clinical Trials

TOFIDENCE showed similar efficacy and a comparable safety profile to reference tocilizumab3,4†

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Patient Support

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*Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product.1

Actemra is represented by EU-approved tocilizumab in the study. Actemra is a registered trademark of Chugai Seiyaku Kabushiki Kaisha Corp., a member of the Roche Group.

 

 

TOFIDENCE is an FDA-approved biosimilar to Actemra

TOFIDENCE is a tocilizumab biosimilar indicated for use in patients with1:

  • 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)
  • Giant Cell Arteritis (GCA) - Adult patients with giant cell arteritis
  • 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
  • Coronavirus Disease 2019 (COVID-19) - Hospitalized adult patients with coronavirus disease 2019 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO)

Similar efficacy and a comparable safety profile to reference tocilizumab for intravenous use3,4

May potentially offer a cost-effective treatment option

TOFIDENCE was evaluated for biosimilarity in an RA clinical study and was granted approval for its other indications through a process called "extrapolation." Extrapolation of clinical data to other indications of the reference product is considered in light of the totality of evidence and must be scientifically justified.5

TOFIDENCE proposed mechanism of action6

Interleukin-6 monoclonal antibody

Adapted from: Fu et al. 2020.

TOFIDENCE binds to both soluble and membrane-bound IL-6 receptors (sIL-6R and mIL-6R), and has been shown to inhibit IL-6–mediated signaling through these receptors1

IL-6 is a pleiotropic pro-inflammatory cytokine produced by a variety of cell types including T- and B-cells, lymphocytes, monocytes, and fibroblasts. IL-6 is also produced by synovial and endothelial cells leading to local production of IL-6 in joints affected by inflammatory processes such as RA1

Multiple clinical trials have demonstrated the efficacy of tocilizumab as monotherapy or in combination with DMARDs for adult patients with moderately to severely active RA1,3,4,7-14

FDA=US Food and Drug Administration.

References
  1. TOFIDENCE Prescribing Information, Cambridge, MA; Biogen.
  2. US Food and Drug Administration. FDA approves first biosimilar to Actemra to treat adult and pediatric arthritis. September 29, 2023. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-biosimilar-actemra-treat-adult-and-pediatric-arthritis. Accessed February 12, 2025.
  3. Leng X, Leszczyński P, Jeka S, et al. A phase 3, randomized, double-blind, active-controlled clinical trial to compare BAT1806/BIIB800, a tocilizumab biosimilar, with tocilizumab reference product in participants with moderate-to-severe rheumatoid arthritis with inadequate response to methotrexate: treatment period 2 analysis (week 24 to week 48). Arthritis Res Ther. 2024;26(1):157.
  4. Leng X, Leszczynski P, Jeka S, et al. Comparing tocilizumab biosimilar BAT1806/BIIB800 with reference tocilizumab in patients with moderate-to-severe rheumatoid arthritis with an inadequate response to methotrexate: a phase 3, randomised, multicentre, double-blind, active-controlled clinical trial. Lancet Rheumatol. 2024.;6(1):E40-E50.
  5. FDA. Biosimilar product regulatory review and approval. 2018. https://www.fda.gov/files/drugs/published/Biosimilar-Product-Regulatory-Review-and-Approval.pdf. Accessed March 2025.
  6. Fu B, Xu X, Wei H. Why tocilizumab could be an effective treatment for severe COVID-19? J Transl Med. 2020;18(1):164.
  7. Nishimoto N, Hashimoto J, Miyasaka N, et al. Study of active controlled monotherapy used for rheumatoid arthritis, an IL-6 inhibitor (SAMURAI): evidence of clinical and radiographic benefit from an x ray reader-blinded randomised controlled trial of tocilizumab. Ann Rheum Dis. 2007;66(9):1162-1167.
  8. Genovese MC, McKay JD, Nasonov EL, et al. Interleukin-6 receptor inhibition with tocilizumab reduces disease activity in rheumatoid arthritis with inadequate response to disease-modifying antirheumatic drugs: the tocilizumab in combination with traditional disease-modifying antirheumatic drug therapy study. Arthritis Rheum. 2008;58(10):2968-2980.
  9. Emery P, Keystone E, Tony HP, et al. IL-6 receptor inhibition with tocilizumab improves treatment outcomes in patients with rheumatoid arthritis refractory to anti-tumour necrosis factor biologicals: results from a 24-week multicentre randomised placebo-controlled trial. Ann Rheum Dis. 2008;67(11):1516-1523.
  10. Smolen JS, Beaulieu A, Rubbert-Roth A, et al. Effect of interleukin-6 receptor inhibition with tocilizumab in patients with rheumatoid arthritis (OPTION study): a double-blind, placebo-controlled, randomised trial. Lancet. 2008;371(9617):987-997.
  11. Nishimoto N, Miyasaka N, Yamamoto K, et al. Study of active controlled tocilizumab monotherapy for rheumatoid arthritis patients with an inadequate response to methotrexate (SATORI): significant reduction in disease activity and serum vascular endothelial growth factor by IL-6 receptor inhibition therapy. Mod Rheumatol. 2009;19(1):12-19.
  12. Jones G, Sebba A, Gu J, et al. Comparison of tocilizumab monotherapy versus methotrexate monotherapy in patients with moderate to severe rheumatoid arthritis: the AMBITION study. Ann Rheum Dis. 2010;69(1):88- 96.
  13. Kremer JM, Blanco R, Brzosko M, et al. Tocilizumab inhibits structural joint damage in rheumatoid arthritis patients with inadequate responses to methotrexate: results from the double-blind treatment phase of a randomized placebo-controlled trial of tocilizumab safety and prevention of structural joint damage at one year. Arthritis Rheum. 2011;63(3):609-621.
  14. Smolen JS, Landewé RBM, Bergstra SA, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2022 update. Ann Rheum Dis. 2023;82(1):3-18.