FDA expands Organon’s TOFIDENCE biosimilar approval to CAR‑T cytokine release syndrome and severe COVID‑19, broadening access to IL‑6 therapy.
Written By: Kirti Kumbar, M. Pharm (QA)
Reviewed By: Pharmacally Editorial Team
The U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for TOFIDENCE® (tocilizumab-bavi), Organon’s biosimilar to ACTEMRA® (tocilizumab).
The approval expands the product’s label to include treatment of severe or life-threatening cytokine release syndrome (CRS) associated with chimeric antigen receptor (CAR) T-cell therapies and certain hospitalized COVID-19 patients.
The decision extends the clinical utility of TOFIDENCE beyond rheumatology and reflects the FDA’s biosimilar regulatory framework, which allows approved biosimilars to gain additional indications based on demonstrated similarity to the reference product.
Expanded Indications
TOFIDENCE is now approved for adults and children aged two years and older with CAR T-cell-induced severe or life-threatening CRS. The therapy is also indicated for hospitalized adult and pediatric COVID-19 patients aged two years and older who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
These approvals align with established treatment strategies that use interleukin-6 (IL-6) inhibition to control excessive inflammatory responses.
Clinical Significance
CRS remains one of the most serious toxicities associated with CAR T-cell therapies. The condition can rapidly progress to widespread systemic inflammation, organ dysfunction, and life-threatening complications, making timely intervention essential. Tocilizumab has become a standard treatment option for managing severe CRS in patients receiving CAR T-cell therapy.
In COVID-19, IL-6 inhibition emerged as an important treatment strategy for hospitalized patients experiencing severe inflammatory complications and respiratory failure. The expanded TOFIDENCE label now provides clinicians and healthcare systems with a lower-cost biosimilar alternative for patient populations where tocilizumab therapy has become an established component of care.
Product Profile
Launched in May 2024, TOFIDENCE was the first FDA-approved tocilizumab biosimilar available in the United States. The product is supplied in single-dose intravenous vials containing 80 mg/4 mL, 200 mg/10 mL, and 400 mg/20 mL, each requiring dilution before infusion.
Prior approved indications included moderately to severely active rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.
Safety Considerations
The expanded label carries the established safety warnings associated with tocilizumab products. Patients receiving TOFIDENCE face an increased risk of serious infections, including tuberculosis, bacterial infections, invasive fungal infections, viral infections, and other opportunistic pathogens that may lead to hospitalization or death.
Clinicians should screen patients for latent tuberculosis before initiating therapy and closely monitor for signs and symptoms of infection during and after treatment. Additional risks associated with tocilizumab products include elevated liver enzymes, neutropenia, and gastrointestinal perforation. Treatment should be interrupted if a serious infection develops.
Commercial Implications
Organon acquired U.S. regulatory and commercial rights to TOFIDENCE in 2025, while Bio-Thera Solutions retains manufacturing responsibilities for the U.S. market.
Jon Martin, U.S. Commercial Lead for Biosimilars and Established Brands at Organon, said the expanded indications represent an important step toward improving access to treatment options for patients facing serious conditions such as CAR T-cell-associated CRS while supporting broader adoption of lower-cost biologic alternatives.
The approval strengthens Organon’s biosimilars portfolio and positions TOFIDENCE for broader use across oncology supportive care, infectious disease, immunology, and critical care settings. By expanding access to a lower-cost biologic alternative, the product may help reduce healthcare expenditures associated with high-priced reference biologics.
Reference
About the Writer
Kirti Kumbhar (LinkedIn) is an M.Pharm graduate with experience in Quality Assurance at Lupin Limited and a strong interest in clinical research, regulatory affairs, and Trial Master File (TMF) management. She has developed knowledge of regulatory documentation, quality systems, compliance, and healthcare research through her professional experience. Passionate about clinical development and continuous learning, Kirti is committed to supporting high-quality healthcare documentation, regulatory excellence, and research-driven healthcare advancements.