NYSE:OGNPharmaceuticals
How FDA’s Expanded TOFIDENCE Approval in CRS and COVID-19 Could Shape Organon’s (OGN) Biosimilar Strategy
In June 2026, Organon reported that the US FDA approved a supplemental Biologics License Application expanding TOFIDENCE, a tocilizumab biosimilar to ACTEMRA, to treat CAR T cell-induced severe cytokine release syndrome and certain hospitalized COVID-19 patients aged 2 years and older.
This makes TOFIDENCE the first tocilizumab biosimilar available in the US across a broad range of autoimmune and acute inflammatory indications, potentially reinforcing Organon’s focus on expanding its...