On 10 June 2026, Organon announced that the FDA has approved its supplemental Biologics License Application (sBLA) for Tofidence® (IV), biosimilar to Genentech’s Actemra® (tocilizumab), expanding the indications to include (a) treatment of patients 2 years and older with CAR-T cell-induced severe or life-threatening cytokine release syndrome (CRS) and (b) hospitalised adult and paediatric patients aged 2 years and older with COVID-19 who are receiving corticosteroids and require supplemental oxygen, ventilation or extracorporeal membrane oxygenation (ECMO).
Organon acquired the US regulatory and commercial rights to Tofidence® (BAT1806) from Biogen in April 2025. Bio-Thera Solutions, the product developer, retains the manufacturing rights for Tofidence® for the US market.
Tofidence® (tocilizumab-bavi) was the first US approved tocilizumab biosimilar (IV formulation approved September 2023; launched May 2024) for the treatment of moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis. This approval was followed by Fresenius Kabi’s Tyenne® (SC formulation approved March 2024; IV formulation launched April 2024; SC formulation launched July 2024), and Celltrion’s Avtozma® (January 2025). Fresenius Kabi’s Tyenne® SC was the first SC tocilizumab formulation to launch in the US.