Newly Approved Tofidence, First Actemra Biosimilar, Expected to Have Some Impact for Payers, Rheumatologists

The FDA recently approved the first biosimilar of Actemra (tocilizumab) from Genentech USA, Inc., a member of the Roche Group, for multiple indications. Both payers and rheumatologists responding to a Zitter Insights survey said they expected the new drug to have some impact on their management of and prescribing for rheumatoid arthritis (RA).

On Sept. 29, the FDA approved Bio-Thera and Biogen Inc.’s Tofidence (tocilizumab-bavi) intravenous formulation for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response to at least one disease-modifying antirheumatic drug, people at least 2 years old with active polyarticular juvenile idiopathic arthritis and people at least 2 years old with active systemic juvenile idiopathic arthritis. Dosing of the intravenous infusion is based on the indication.

It is the first FDA-approved biosimilar of interleukin-6 inhibitor Actemra, which is approved in both intravenous and subcutaneous formulations. In addition, the reference drug has four additional FDA-approved indications: (1) treating adults with giant cell arteritis, (2) slowing the rate of decline in pulmonary function in adults with systemic sclerosis-associated interstitial lung disease, (3) treating people at least 2 years old with chimeric antigen receptor T-cell (CAR-T)-induced severe or life-threatening cytokine release syndrome, and (4) treating hospitalized adults with COVID-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO).

Biogen will commercialize Tofidence in the U.S., and the company said it is “evaluating the potential launch timeline” for the agent.

For the Managed Care Biologics & Injectables Index: Q2 2023, from May 24, 2023, to June 30, 2023, Zitter Insights polled 36 commercial payers covering 116.6 million lives, 29 Medicare payers representing 43.3 million lives and 50 rheumatologists about their management and prescribing of RA therapies, including the anticipated impact of Tofidence. Payers representing 87% of commercial lives and 72% of Medicare beneficiaries rated managing branded RA treatments as a high or very high priority.

Payers with approximately three-quarters of commercial and Medicare lives said that they were either somewhat or moderately aware of Tofidence, which is also known as BAT1806. That’s compared with 30% of rheumatologists who ranked their awareness at a similar level.

Both AIS Health and Zitter Insights are divisions of MMIT.

Payers varied on their estimations of the biosimilar’s impact on available RA drugs, although none said they expected it to have a very high impact (see chart). The majority of rheumatologists — 58% — said they expect that Tofidence will have some impact on their treatment approach for patients, meaning that they anticipate it will remain mostly unchanged, but they may alter it with select current patients.

For more information on the Zitter Insights data, contact Jill Brown Kettler at


© 2024 MMIT
Angela Maas

Angela Maas

Angela has an extensive background of editing, reporting and writing for trade and consumer publications. She has written Radar on Specialty Pharmacy since she joined AIS Health in 2005 and has broad knowledge of the various issues at play within the space. She also has written for Spotlight on Market Access since its 2017 launch. Before joining AIS Health, she was managing editor at Employee Benefit News and Employee Benefit News Canada and managing editor at Hem Aware (a hemophilia publication), Lupus Living and Momentum (a multiple sclerosis publication). She has a B.A. in English and an M.A. in British literature from Arizona State University.

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