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Organon Secures US Food and Drug Administration Approval Expanding Indications for TOFIDENCE® (tocilizumab-bavi) in Cytokine Release Syndrome (CRS) and Pediatric COVID-19
Organon Secures US Food and Drug Administration Approval Expanding Indications for TOFIDENCE® (tocilizumab-bavi) in Cytokine Release Syndrome (CRS) and
About this update from Organon & Co.
Organon (NYSE: OGN) today announced the US Food and Drug Administration (FDA) approval of the supplemental Biologics License Application (sBLA) for TOFIDENCE® (tocilizumab-bavi) injection, for intravenous use, a biosimilar to ACTEMRA (tocilizumab). The approval expands TOFIDENCE indications to include treatment of: (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 aged 2 years and older with coronavirus disease 2019 (COVID-19) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). “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,” said Jon Martin, US Commercial Lead, Biosimilars and Established Brands at Organon.1,2 “In the US, biosimilar adoption may help reduce the affordability burden of high-cost brand biologics on the health care system.3 By expanding the use of TOFIDENCE, we continue to advance our biosimilars portfolio and our commitment to broadening access to high-quality treatment options for patients in need.”1,3 TOFIDENCE, the first approved tocilizumab biosimilar entrant in the US market, was launched in May 2024 and is also indicated in appropriate patients for the treatment of moderately to severely active rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.4,5 See full indications below. TOFIDENCE injection is available in the following presentations: 80 mg/4 mL (20 mg/mL), 200 mg/10 mL (20 mg/mL), 400 mg/20mL (20 mg/mL), in single-dose vials for further dilution prior to intravenous infusion. Patients treated with tocilizumab products, including TOFIDENCE, are at increased risk for developing serious infections that may lead to hospitalization or death, including tuberculosis (TB), bacterial, invasive fungal, viral, or other opportunistic infections. If a serious infection develops, interrupt TOFIDENCE until the infection is controlled. Patients should be closely monitored for the development of signs and sy...