Organon Secures US Food and Drug Administration Approval Expanding Indications for TOFIDENCE® (tocilizumab-bavi) in Cytokine Release Syndrome (CRS) and Pediatric COVID-19
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 symptoms of infection during and after treatment with TOFIDENCE, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy. See additional safety information below.
Organon acquired the regulatory and commercial rights to TOFIDENCE in the US in 2025. Bio-Thera Solutions Ltd., the product developer, maintains manufacturing rights for TOFIDENCE for the US market.5
About TOFIDENCE® (tocilizumab-bavi)
TOFIDENCE is an interleukin-6 (IL-6) receptor antagonist indicated for:
- Rheumatoid Arthritis (RA): TOFIDENCE is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs).
- Giant Cell Arteritis (GCA): TOFIDENCE is indicated for the treatment of giant cell arteritis (GCA) in adult patients.
- Polyarticular Juvenile Idiopathic Arthritis (PJIA): TOFIDENCE is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (PJIA) in patients 2 years of age and older.
- Systemic Juvenile Idiopathic Arthritis (SJIA): TOFIDENCE is indicated for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients 2 years of age and older.
- Cytokine Release Syndrome (CRS): TOFIDENCE is indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and pediatric patients 2 years of age and older.
- Coronavirus Disease 2019 (COVID-19): TOFIDENCE is indicated for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adult and pediatric patients aged 2 years and older who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
SELECTED SAFETY INFORMATION
RISK OF SERIOUS INFECTIONS
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.
Reported infections include:
- Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients, except those with COVID-19, should be tested for latent tuberculosis before TOFIDENCE use and during therapy. Treatment for latent infection should be initiated prior to TOFIDENCE use.
- Invasive fungal infections, including candidiasis, aspergillosis, and pneumocystis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.
- Bacterial, viral, and other infections due to opportunistic pathogens.
Do not administer TOFIDENCE in patients with an active infection, including localized infections. The risks and benefits of treatment with TOFIDENCE should be carefully considered prior to initiating therapy in patients:
- with chronic or recurrent infection;
- who have been exposed to tuberculosis;
- with a history of serious or an opportunistic infection;
- who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or
- with underlying conditions that may predispose them to infection.
Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with TOFIDENCE, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.
Hold TOFIDENCE if a patient develops a serious infection, an opportunistic infection, or sepsis. A patient who develops a new infection during treatment with TOFIDENCE should undergo a prompt and complete diagnostic workup appropriate for an immunocompromised patient, initiate appropriate antimicrobial therapy, and closely monitor the patient.
COVID-19
In patients with COVID-19, monitor for signs and symptoms of new infections during and after treatment with TOFIDENCE.
Tuberculosis
Evaluate patients for tuberculosis risk factors and test for latent infection prior to initiating TOFIDENCE.
Consider anti-tuberculosis therapy prior to initiation of TOFIDENCE in patients with a history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent tuberculosis but having risk factors for tuberculosis infection.
Closely monitor patients for the development of signs and symptoms of tuberculosis including patients who tested negative for latent tuberculosis infection prior to initiating therapy.
Patients with latent tuberculosis should be treated with standard antimycobacterial therapy before initiating TOFIDENCE.
Viral Reactivation
Viral reactivation has been reported with immunosuppressive biologic therapies and cases of herpes zoster exacerbation were observed in clinical studies with tocilizumab.
CONTRAINDICATIONS
TOFIDENCE is contraindicated in patients with known hypersensitivity to tocilizumab products.
WARNINGS AND PRECAUTIONS
GASTROINTESTINAL PERFORATIONS
Use TOFIDENCE with caution in patients who may be at increased risk for gastrointestinal perforation. Promptly evaluate patients presenting with fever, new onset abdominal symptoms, and change in bowel habits for early identification of gastrointestinal perforation.
HEPATOTOXICITY
Serious cases of hepatic injury have been observed in patients taking intravenous tocilizumab products. Some of these cases have resulted in liver transplant or death.
For rheumatoid arthritis (RA) and giant cell arteritis (GCA) patients, obtain a liver test panel (serum alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase, and total bilirubin) before initiating TOFIDENCE routinely. It is not recommended to initiate TOFIDENCE treatment in RA and GCA patients with elevated transaminases ALT or AST greater than 1.5 x upper limit of normal (ULN). In patients who develop elevated ALT or AST greater than 5 x ULN, discontinue TOFIDENCE.
It is not recommended to initiate TOFIDENCE treatment in COVID-19 patients with elevated ALT or AST above 10 x ULN. Monitor ALT and AST during treatment.
Measure liver tests promptly in patients who report symptoms that may indicate liver injury, such as fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice. If the patient is found to have abnormal liver tests, TOFIDENCE treatment should be interrupted and investigation done to establish the probable cause. TOFIDENCE should only be restarted in patients with another explanation for the liver test abnormalities after normalization of the liver tests.
A similar pattern of liver enzyme elevation is noted with tocilizumab products treatment in the polyarticular juvenile idiopathic arthritis (PJIA) and systemic juvenile idiopathic arthritis (SJIA) populations. Monitor liver test panel at the time of the second administration and thereafter every 4 to 8 weeks for PJIA and every 2 to 4 weeks for SJIA.
CHANGES IN LABORATORY PARAMETERS
Patients with RA, GCA, and COVID-19:
Neutropenia
Treatment with tocilizumab products was associated with a higher incidence of neutropenia.
It is not recommended to initiate TOFIDENCE treatment in RA and GCA patients with a low neutrophil count, ie, absolute neutrophil count (ANC) less than 2000 per mm3. In patients who develop an ANC less than 500 per mm3, treatment is not recommended. It is not recommended to initiate TOFIDENCE treatment in COVID-19 patients with an ANC less than 1000 per mm3. Neutrophils should be monitored.
Monitor neutrophils 4 to 8 weeks after start of therapy and every 3 months thereafter.
Thrombocytopenia
Treatment with tocilizumab products was associated with a reduction in platelet counts.
It is not recommended to initiate TOFIDENCE treatment in RA and GCA patients with a platelet count below 100,000 per mm3. In patients who develop a platelet count less than 50,000 per mm3, treatment is not recommended.
Monitor platelets 4 to 8 weeks after start of therapy and every 3 months thereafter.
In COVID-19 patients with a platelet count less than 50,000 per mm3, treatment is not recommended.
Elevated Liver Enzymes
Refer to Hepatotoxicity. (See above.)
Lipid Abnormalities
Treatment with tocilizumab products was associated with increases in lipid parameters such as total cholesterol, triglycerides, LDL cholesterol, and/or HDL cholesterol.
Assess lipid parameters approximately 4 to 8 weeks following initiation of TOFIDENCE therapy.
Patients with Polyarticular and Systemic Juvenile Idiopathic Arthritis:
A similar pattern of liver enzyme elevation, low neutrophil count, low platelet count, and lipid elevations is noted with tocilizumab products treatment in the PJIA and SJIA populations. Monitor neutrophils, platelets, ALT, and AST at the time of the second administration and thereafter every 4 to 8 weeks for PJIA and every 2 to 4 weeks for SJIA. Monitor lipids as above for approved adult indications.
IMMUNOSUPPRESSION
TOFIDENCE is an immunosuppressant, and treatment with immunosuppressants may result in an increased risk of malignancies.
HYPERSENSITIVITY REACTIONS, INCLUDING ANAPHYLAXIS
Hypersensitivity reactions, including anaphylaxis, have been reported in association with tocilizumab products and anaphylactic events with a fatal outcome have been reported with intravenous infusion of tocilizumab products. Reactions that required treatment discontinuation included generalized erythema, rash, and urticaria.
TOFIDENCE for intravenous use should only be infused by a healthcare professional with appropriate medical support to manage anaphylaxis. If a hypersensitivity reaction occurs, immediately discontinue TOFIDENCE; treat promptly, and monitor until signs and symptoms resolve.
DEMYELINATING DISORDERS
Prescribers should exercise caution in considering the use of TOFIDENCE in patients with preexisting or recent onset demyelinating disorders.
ACTIVE HEPATIC DISEASE AND HEPATIC IMPAIRMENT
Treatment with TOFIDENCE is not recommended in patients with active hepatic disease or hepatic impairment.
VACCINATIONS
Avoid use of live vaccines concurrently with TOFIDENCE as clinical safety has not been established.
No data are available on the effectiveness of vaccination in patients receiving tocilizumab products. Because interleukin-6 (IL-6) inhibition may interfere with the normal immune response to new antigens, it is recommended that all patients, particularly pediatric or elderly patients, if possible, be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating TOFIDENCE therapy.
ADVERSE REACTIONS
The most common adverse reactions (incidence of at least 5%) associated with tocilizumab-IV were upper respiratory tract infection, nasopharyngitis, headache, hypertension, and increased ALT.
DRUG INTERACTIONS
Cytochrome P450s in the liver are down-regulated by infection and inflammation stimuli including cytokines such as IL-6. Inhibition of IL-6 signaling in RA patients treated with tocilizumab products may restore CYP450 activities to higher levels than those in the absence of tocilizumab products leading to increased metabolism of drugs that are CYP450 substrates.
Exercise caution when coadministering TOFIDENCE with CYP3A4 substrate drugs where decrease in effectiveness is undesirable, eg, oral contraceptives, lovastatin, atorvastatin, etc.
USE IN SPECIFIC POPULATIONS
Pregnancy
The available data with tocilizumab products from a pregnancy exposure registry, retrospective cohort study, pharmacovigilance, and published literature are insufficient to draw conclusions about a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Based on the animal data, there may be a potential risk to the fetus.
Lactation
No information is available on the presence of tocilizumab products in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. Discontinue the drug or nursing, taking into consideration the importance of the drug to the mother.
Before prescribing TOFIDENCE, please read the Prescribing Information, including the Boxed Warning about serious infections. The Medication Guide also is available.
About Organon
Organon (NYSE:OGN) is a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day. With a portfolio of over 70 products across Women's Health and General Medicines, which includes biosimilars, Organon focuses on addressing health needs that uniquely, disproportionately or differently affect women, while expanding access to essential treatments in over 140 markets.
Headquartered in Jersey City, New Jersey, Organon is committed to advancing access, affordability, and innovation in healthcare. Learn more at www.organon.com and follow us on LinkedIn, Instagram, X, YouTube, TikTok and Facebook.
Cautionary Note Regarding Forward-Looking Statements
This press release includes "forward-looking statements" within the meaning of the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about Organon's expectations regarding the anticipated impact and potential benefits to Organon of the expanded indications for TOFIDENCE. Forward-looking statements may be identified by words such as "will," "may," "continue," "commitment to broadening," and words of similar meaning. These statements are based upon the current beliefs and expectations of Organon's management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate, or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Factors that could cause results to differ materially from those described in the forward-looking statements can be found in Organon's filings with the SEC, including Organon's most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and other SEC filings, available at the SEC's Internet site (www.sec.gov). Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
ACTEMRA is a trademark registered in the US by Chugai Seiyaku Kabushiki Kaisha; Organon is not associated with this trademark owner.
References
- Overview for health care professionals. US Food and Drug Administration. Updated August 1, 2024. Accessed February 23, 2026. https://www.fda.gov/drugs/biosimilars/overview-health-care-professionals
- Cytokine release syndrome. Cleveland Clinic. Updated July 14, 2025. Accessed May 27, 2026. https://my.clevelandclinic.org/health/diseases/22700-cytokine-release-syndrome
- Aitken M, Kleinrock M, Pritchett J. Biosimilars in the United States 2023-2027: competition, savings, and sustainability. IQVIA Institute for Human Data Science. January 31, 2023. Accessed February 5, 2026. https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/biosimilars-in-the-united-states-2023-2027
- FDA approves first biosimilar to Actemra to treat adult and pediatric arthritis. US Food and Drug Administration; September 29, 2023. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-biosimilar-actemra-treat-adult-and-pediatric-arthritis
- Organon acquires TOFIDENCE™ (tocilizumab-bavi), a commercialized biosimilar to ACTEMRA® (tocilizumab) injection, for intravenous infusion in the U.S. Press release. Organon; April 1, 2025. https://www.organon.com/news/organon-acquires-tofidence-tocilizumab-bavi-a-commercialized-biosimilar-to-actemra-tocilizumab-injection-for-intravenous-infusion-in-the-u-s/
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