Shots:
- The US FDA has approved sBLA for Tofidence, a biosimilar version of Actemra (tocilizumab)
- Tofidence is an IL-6 receptor antagonist available in 80 mg/4 mL, 200 mg/10 mL, and 400 mg/20 mL single-dose vials for IV. The expanded approval adds indications for CAR T cell-induced severe or life-threatening cytokine release syndrome (CRS) and hospitalized adults and children (≥2 years) with COVID-19 requiring corticosteroids and respiratory support, including oxygen, mechanical ventilation, or ECMO
- In 2025, Organon acquired the US regulatory and commercial rights to Tofidence, while Bio-Thera Solutions retained US manufacturing rights
Ref: Businesswire | Image: Organon |Press Release
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