Organon expands TOFIDENCE indications for CRS and COVID-19
Organon announced FDA approval for TOFIDENCE to treat CAR T cell-induced CRS and severe COVID-19. The expansion addresses critical patient needs and aims to reduce healthcare costs through biosimilar adoption.
*this image is generated using AI for illustrative purposes only.
Organon announced the US Food and Drug Administration (FDA) approval of the supplemental Biologics License Application (sBLA) for TOFIDENCE (tocilizumab-bavi) injection, expanding its indications to treat critical conditions. The approval specifically includes adults and pediatric patients 2 years of age and older with chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS). Additionally, it covers hospitalized adult and pediatric patients aged 2 years and older with coronavirus disease 2019 (COVID-19) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
Jon Martin, US Commercial Lead, Biosimilars and Established Brands at Organon, stated that the approval addresses critical needs for patients facing CRS, a serious side effect of CAR-T therapies. He noted that biosimilar adoption may help reduce the affordability burden of high-cost brand biologics on the healthcare system. By expanding the use of TOFIDENCE, the company aims to advance its biosimilars portfolio and broaden access to treatment options.
TOFIDENCE is the first approved tocilizumab biosimilar entrant in the US market, launched in May 2024. It is also indicated for the treatment of moderately to severely active rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis. Organon acquired the regulatory and commercial rights to TOFIDENCE in the US in 2025, while Bio-Thera Solutions Ltd. retains manufacturing rights for the US market.
The product is available in single-dose vials for further dilution prior to intravenous infusion in the following presentations: 80 mg/4 mL (20 mg/mL), 200 mg/10 mL (20 mg/mL), and 400 mg/20 mL (20 mg/mL). Patients treated with tocilizumab products, including TOFIDENCE, are at increased risk for developing serious infections that may lead to hospitalization or death, including tuberculosis, bacterial, invasive fungal, viral, or other opportunistic infections.
Approved Indications
| Indication | Patient Population |
|---|---|
| Rheumatoid Arthritis (RA) | Adults with moderately to severely active RA who have had an inadequate response to one or more DMARDs |
| Giant Cell Arteritis (GCA) | Adult patients |
| Polyarticular Juvenile Idiopathic Arthritis (PJIA) | Patients 2 years of age and older |
| Systemic Juvenile Idiopathic Arthritis (SJIA) | Patients 2 years of age and older |
| Cytokine Release Syndrome (CRS) | Adults and pediatric patients 2 years of age and older with CAR T cell-induced severe or life-threatening CRS |
| Coronavirus Disease 2019 (COVID-19) | Hospitalized adults and pediatric patients aged 2 years and older receiving systemic corticosteroids and requiring supplemental oxygen, mechanical ventilation, or ECMO |
The FDA approval mandates specific safety monitoring, including the interruption of TOFIDENCE if a serious infection develops until the infection is controlled. Patients should be closely monitored for signs and symptoms of infection during and after treatment.
How will the introduction of the first tocilizumab biosimilar impact the pricing strategies of the reference biologic manufacturer?
What market share is Organon targeting to capture within the CAR-T and severe COVID-19 treatment segments over the next year?
Could this FDA approval accelerate the development and regulatory acceptance of biosimilars for other critical care indications?
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