Organon Secures US Food and Drug Administration Approval Expanding Indications for TOFIDENCE® (tocilizumab-bavi) in Cytokine Release Syndrome (CRS) and Pediatric COVID-19
Organon received FDA approval for two new indications for TOFIDENCE, its tocilizumab biosimilar: treatment of cytokine release syndrome (CRS) in CAR-T patients and hospitalized pediatric COVID-19 cases. TOFIDENCE, the first approved tocilizumab biosimilar in the US, launched in May 2024. Organon acquired US rights to the asset in 2025 from developer Bio-Thera Solutions.
Key figures
- Drug Name
- TOFIDENCE (tocilizumab-bavi)
- Launch date
- May 2024
- Acquisition year
- 2025
- Product presentations
- ["80 mg/4 mL","200 mg/10 mL","400 mg/20 mL"]
AI analysis
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