FDA has approved Organon's tocilizumab-bavi (Tofidence) for CAR T-cell–induced CRS and hospitalized COVID-19 in adults and children aged 2 years or older.
Organon announced that
“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
The expanded label covers 2 acute
Tofidence is an interleukin-6 (IL-6) receptor antagonist that was first approved by FDA in 2023, at which time it was considered the first US biosimilar to Actemra. The initial indications for which Tofidence was approved revolved around selected adult and pediatric inflammatory conditions, including moderately to severely active rheumatoid arthritis after inadequate response to 1 or more disease-modifying antirheumatic drugs, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.2 Organon reported that the product launched in May 2024 and that the company acquired US regulatory and commercial rights in 2025 from Bio-Thera Solutions. The latter retained US manufacturing rights.1
Organon did not report new randomized efficacy or safety data for tocilizumab-bavi in CRS or COVID-19 with its latest announcement. As with biosimilar approvals generally, the regulatory determination depends on demonstrating high similarity to the reference biologic, with no clinically meaningful differences in safety, purity, and potency, and may support use across approved indications when scientific justification is adequate.2
CRS is a potentially serious immune-mediated toxicity of CAR-T therapy that is driven by immune activation and elevated inflammatory cytokines, including IL-6. Tocilizumab (Actemra) became a key therapeutic option after FDA review of retrospective clinical data in CAR T-cell–associated CRS. At that time, FDA’s approval summary for Actemra described its role in severe or life-threatening CRS following CAR-T therapies.3 Clinically, treatment management often also includes supportive care and corticosteroids, depending on severity, product-specific guidance, and institutional protocols.
For hospitalized COVID-19, the clinical rationale for inhibiting the IL-6 pathway was supported by large platform trials conducted during the pandemic. In one trial (RECOVERY), Actemra added to usual care reduced 28-day mortality among hospitalized patients with hypoxia and systemic inflammation, most of whom were receiving corticosteroids, and increased the probability of discharge alive within 28 days.4 The expanded Tofidence indication is narrower than “all hospitalized COVID-19” and is tied to concomitant systemic corticosteroids plus oxygen, ventilatory support, or extracorporeal membrane oxygenation requirements.1
The boxed warning for tocilizumab products remains central to prescribing these therapies. Patients receiving Tofidence are at increased risk for serious infections that may lead to hospitalization or death, including tuberculosis, bacterial infections, invasive fungal infections, viral infections, and other opportunistic infections. Organon’s safety information states that Tofidence should be interrupted if a serious infection develops and should not be administered to patients with active infections, including localized infections, outside the COVID-19 context described in labeling.1
Other warnings include gastrointestinal perforation, hepatotoxicity, laboratory abnormalities (including neutropenia and thrombocytopenia), lipid elevations, hypersensitivity reactions including anaphylaxis, demyelinating disorders, and avoidance of live vaccines during treatment.1 For COVID-19, the label specifies monitoring for new infections during and after therapy and recommends against initiation in patients with alanine aminotransferase or aspartate aminotransferase levels above 10 times the upper limit of normal or absolute neutrophil count below 1000/mm.1,3
The sBLA approval may expand biosimilar competition in high-cost biologic categories, but the immediate clinical impact may depend on formulary decisions, institutional CAR T-cell toxicity pathways, COVID-19 treatment protocols, payer coverage, and clinician confidence in biosimilar substitution policies. Remaining evidence questions include real-world uptake, outcomes in pediatric acute-care settings, and pharmacovigilance in immunocompromised populations treated for CRS or severe COVID-19.
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