On June 10, 2026, Organon announced that the U.S. Food and Drug Administration (FDA) approved a supplemental biologics license application (sBLA) for TOFIDENCE ® (tocilizumab-bavi), an intravenous biosimilar to Genentech’s ACTEMRA® (tocilizumab). The approval expands TOFIDENCE’s indications to include: (1) adults and pediatric patients (2 years of age and older) with chimeric antigen receptor (CAR) T cell–induced severe or life-threatening cytokine release syndrome (CRS), and (2) hospitalized adult and pediatric patients (2 years of age and older) with COVID-19 who are receiving systemic corticosteroids and require supplemental oxygen or other respiratory support.
Jon Martin, U.S. Commercial Lead, Biosimilars and Advanced Brands at Organon, stated: “the approval of these new indications for TOFIDENCE is a vital step forward in expanding access to treatment options that address critical needs, including for patients facing CRS, a serious side effect of CAR-T therapies.”
TOFIDENCE was the first approved tocilizumab biosimilar in the U.S. market, having launched in May 2024 after receiving FDA approval in September 2023. It was previously approved by FDA for patients with rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.
Stay tuned to Big Molecule Watch for further developments in the biosimilars industry.