Organon announced on Wednesday that the U.S. Food and Drug Administration (FDA) has approved expanded indications for TOFIDENCE (tocilizumab-bavi), allowing the biosimilar medicine to be used for cytokine release syndrome (CRS) associated with certain cancer treatments and for COVID-19 patients who require respiratory support.
The FDA approved a supplemental Biologics License Application for TOFIDENCE, an intravenous biosimilar to Roche’s Actemra (tocilizumab). The expanded approval covers adults and pediatric patients aged two years and older with chimeric antigen receptor (CAR) T cell-induced severe or life-threatening CRS.
The authorization also includes hospitalized adults and children aged two years and older with COVID-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
According to Organon, CRS is a condition in which the body releases excessive inflammatory proteins. The company said TOFIDENCE can now be used in adults and children aged two years and older for both the newly approved indications.
“The approval of these new indications for TOFIDENCE is a vital step forward in expanding access to treatment options that address critical needs, including for patients facing CRS, a serious side effect of CAR-T therapies,” said Jon Martin, U.S. Commercial Lead, Biosimilars and Established Brands at Organon.
Martin also stated that adoption of biosimilars in the United States may help reduce the affordability burden associated with high-cost brand biologics on the healthcare system. He added that by expanding the use of TOFIDENCE, the company continues to advance its biosimilars portfolio and its commitment to broadening access to treatment options.
Organon said TOFIDENCE was approved by the FDA in 2023 as the first U.S. biosimilar to Actemra. The product was launched in May 2024 and is also indicated in appropriate patients for the treatment of moderately to severely active rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.
TOFIDENCE is available in single-dose vials in three presentations: 80 mg/4 mL (20 mg/mL), 200 mg/10 mL (20 mg/mL), and 400 mg/20 mL (20 mg/mL). The vials are intended for further dilution before intravenous infusion.
Organon noted that patients treated with tocilizumab products, including TOFIDENCE, are at increased risk of developing serious infections that may lead to hospitalization or death. These infections include tuberculosis, bacterial infections, invasive fungal infections, viral infections, and other opportunistic infections. The company said treatment should be interrupted if a serious infection develops until the infection is controlled. Patients should also be closely monitored for signs and symptoms of infection during and after treatment, including the possible development of tuberculosis in individuals who tested negative for latent tuberculosis infection before beginning therapy.
The company acquired the regulatory and commercial rights to TOFIDENCE in the United States in 2025. Bio-Thera Solutions, the developer of the product, retains manufacturing rights for the U.S. market.
Separately, in April, India’s Sun Pharmaceutical Industries announced plans to acquire Organon in an all-cash transaction valued at approximately $11.75 billion, including debt. Organon said the transaction would represent the largest overseas acquisition by an Indian pharmaceutical company.
Tofidence has received FDA approval for expanded indications covering cytokine release syndrome (CRS) and certain COVID-19-related treatment applications. The approval marks an important milestone for Tofidence, broadening its clinical utility and increasing treatment options for healthcare providers managing severe inflammatory conditions.
The expanded approval further strengthens the position of Tofidence within the growing biologics and biosimilars market, where demand continues to rise for effective and cost-efficient therapies.
What the Approval Means for Tofidence
The latest FDA decision allows Tofidence to be used in additional clinical settings where controlling excessive immune responses is critical. Cytokine release syndrome is a potentially life-threatening condition that can occur after certain immunotherapies, making effective treatment options essential.
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