For US healthcare professionals only
Q-code: Q5156
Q-code: Q5156

Why prescribe AVTOZMA?

AVTOZMA is an FDA-approved biosimilar of Actemra, with similar indications, efficacy, safety, and MOA1,2

Comparable efficacy and safety to Actemra—shown to 52 weeks3

Proven similarity to Actemra1,4

FDA-approved and interchangeable–
NO clinically meaningful differences in:

  • Efficacy
  • Safety
  • Pharmacokinetics/
    pharmacodynamics
  • Immunogenicity

Backed by Celltrion’s patient and practice support programs

Manufactured by Celltrion, a global leader in biopharmaceuticals

FDA, Food and Drug Administration; MOA, mechanism of action.

AVTOZMA and Actemra showed similar improvement in RA

AVTOZMA and Actemra showed similar results at weeks 12 and 244

Explore results

Mean DAS28-ESR score improvement from baseline at weeks 12 and 244

  • Mean change from baseline in DAS28-ESR at weeks 12 and 24 was assessed as the primary endpoint4*
  • For the demonstration of efficacy, the 95% and 90% CIs for the treatment differences at week 12 and week 24, respectively, were entirely contained within the predefined equivalence margins of -0.6 to 0.6 and -0.6 to 0.5. This demonstrated therapeutic equivalence between AVTOZMA and Actemra groups in the mean change from baseline DAS28-ESR at
    • Week 12 analysis (ANCOVA, ITT): treatment difference = −0.01 (95% CI −0.26, 0.24)4
    • Week 24 analysis (ANCOVA with multiple imputation, ITT): treatment difference = −0.10 (90% CI −0.30, 0.10)4
  • Based partly on the findings of this study, AVTOZMA has been approved as biosimilar to Actemra across all Actemra indications, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, cytokine release syndrome, and COVID-19 in hospitalized adult patients requiring supplemental oxygen or ventilation support1,4
  • The FDA looks at a wide variety of tests and data to determine that a drug is biosimilar to another, including clinical trials, blood and immune system evaluations, and chemical analyses. AVTOZMA passed those tests and is officially biosimilar to Actemra2,4

ANCOVA, analysis of covariance; CI, confidence interval; DAS28-ESR, Disease Activity Score in 28 joints using ESR, erythrocyte sedimentation rate; ITT, intent-to-treat.

*The DAS28 is a measurement to assess disease activity in patients with rheumatoid arthritis that includes the following 4 items: number of painful joints out of 28 assessed joints; number of swollen joints out of 28 assessed joints; the erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP) concentration; and a visual analogue scale (VAS) that measures the patient’s general health.5

Explore results

AVTOZMA dosing is similar to Actemra

AVTOZMA offers similar indications and strength as Actemra so it can be integrated into your existing treatment protocol1,6

Learn more

Celltrion offers comprehensive support for AVTOZMA

We can help you empower your patients to navigate their treatment journeys confidently and seamlessly.

Find resources

References: 1. AVTOZMA Prescribing Information. Celltrion USA, Inc; 2025. 2. US Food and Drug Administration. Biosimilar Product Regulatory Review and Approval. Accessed March 17, 2025. https://www.fda.gov/files/drugs/published/Biosimilar-Product-Regulatory-Review-and-Approval.pdf 3. Burmester G, Trefler J, Racewicz A, et al. Similar efficacy, PK, safety, and immunogenicity of tocilizumab biosimilar (CT-P47) and reference tocilizumab in patients with moderate-to-severe active rheumatoid arthritis: week 52 results from the phase III single transition study [abstract]. Arthritis Rheumatol. 2024;76(suppl 9). Accessed July 9, 2025. https://acrabstracts.org/abstract/similar-efficacy-pk-safety-and-immunogenicity-of-tocilizumab-biosimilar-ct-p47-and-reference-tocilizumab-in-patients-with-moderate-to-severe-active-rheumatoid-arthritis-week-52-results-from-the/ 4. Smolen JS, Trefler J, Racewicz A, et al. Efficacy and safety of CT-P47 versus reference tocilizumab: 32-week results of a randomised, active-controlled, double-blind, phase III study in patients with rheumatoid arthritis, including 8 weeks of switching data from reference tocilizumab to CT-P47. RMD Open. 2024;10:e004514. doi: 10.1136/rmdopen-2024-004514 5. Inoue E, Yamanaka H, Hara M, Tomatsu T, Kamatani N. Comparison of Disease Activity Score (DAS)28-erythrocyte sedimentation rate and DAS28-C-reactive protein threshold values. Ann Rheum Dis. 2007;66:407-409. 6. ACTEMRA Prescribing Information. Genentech, Inc; 2024.

References: 1. AVTOZMA Prescribing Information. Celltrion USA, Inc; 2025. 2. US Food and Drug Administration. Biosimilar Product Regulatory Review and Approval. Accessed March 17, 2025. https://www.fda.gov/files/drugs/published/Biosimilar-Product-Regulatory-Review-and-Approval.pdf 3. Burmester G, Trefler J, Racewicz A, et al. Similar efficacy, PK, safety, and immunogenicity of tocilizumab biosimilar (CT-P47) and reference tocilizumab in patients with moderate-to-severe active rheumatoid arthritis: week 52 results from the phase III single transition study [abstract]. Arthritis Rheumatol. 2024;76(suppl 9). Accessed July 9, 2025. https://acrabstracts.org/abstract/similar-efficacy-pk-safety-and-immunogenicity-of-tocilizumab-biosimilar-ct-p47-and-reference-tocilizumab-in-patients-with-moderate-to-severe-active-rheumatoid-arthritis-week-52-results-from-the/ 4. Smolen JS, Trefler J, Racewicz A, et al. Efficacy and safety of CT-P47 versus reference tocilizumab: 32-week results of a randomised, active-controlled, double-blind, phase III study in patients with rheumatoid arthritis, including 8 weeks of switching data from reference tocilizumab to CT-P47. RMD Open. 2024;10:e004514. doi:10.1136/rmdopen-2024-004514 5. Inoue E, Yamanaka H, Hara M, Tomatsu T, Kamatani N. Comparison of Disease Activity Score (DAS)28-erythrocyte sedimentation rate and DAS28-C-reactive protein threshold values. Ann Rheum Dis. 2007;66:407-409. 6. ACTEMRA Prescribing Information. Genentech, Inc; 2024.

IMPORTANT SAFETY INFORMATION

WARNING: RISK OF SERIOUS INFECTIONS

Patients treated with tocilizumab products including AVTOZMA are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

If a serious infection develops, interrupt AVTOZMA 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 AVTOZMA use and during therapy. Treatment for latent infection should be initiated prior to AVTOZMA 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.

The risks and benefits of treatment with AVTOZMA should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.

Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with AVTOZMA, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.

Contraindications: Known hypersensitivity to tocilizumab products.

Serious Infections. Serious and sometimes fatal infections, including bacterial, mycobacterial, invasive fungal, viral, and opportunistic infections, have been reported with tocilizumab products, including AVTOZMA. Common serious infections include pneumonia, urinary tract infections, cellulitis, herpes zoster, and sepsis, while opportunistic infections such as tuberculosis and cryptococcus have also occurred. Patients with chronic or recurrent infections, tuberculosis exposure, or underlying conditions predisposing to infections should have the risks and benefits of AVTOZMA carefully evaluated. Monitor patients closely during and after treatment for signs of infection, and discontinue AVTOZMA if a serious infection develops, initiating appropriate antimicrobial therapy as needed.

Gastrointestinal (GI) Perforation. Gastrointestinal perforation events, primarily associated with diverticulitis, have been reported in clinical trials of tocilizumab. Use AVTOZMA cautiously in patients at increased risk for gastrointestinal perforation. Promptly evaluate any patient experiencing new abdominal symptoms to ensure early detection and management of this condition.

Hepatotoxicity. Serious hepatic injury, including cases of liver transplant and death, has occurred with tocilizumab products, with onset ranging from months to years. Some cases involved marked transaminase elevations (>5x ULN), while others presented with mild elevations and symptoms of liver dysfunction. Risk is higher with hepatotoxic drugs like methotrexate. Baseline and regular liver tests are required for RA, GCA, PJIA, and SJIA patients, with specific monitoring intervals based on the condition. Do not initiate AVTOZMA if ALT or AST >1.5x ULN (RA/GCA) or >10x ULN (COVID-19), and discontinue if ALT or AST >5x ULN. Evaluate symptoms of liver injury promptly, and only restart treatment if liver test abnormalities are resolved and attributed to another cause.

Changes in Laboratory Parameters. Treatment with tocilizumab products, including AVTOZMA, has been associated with neutropenia, thrombocytopenia, elevated liver enzymes, and lipid abnormalities. Infections are uncommon with treatment-related neutropenia, but AVTOZMA should not be initiated in RA or GCA patients with ANC <2000/mm³ or platelet counts <100,000/mm³, and treatment is not recommended if ANC drops below 500/mm³ or platelets below 50,000/mm³. For COVID-19 patients, AVTOZMA is not recommended with ANC <1000/mm³ or platelets <50,000/mm³. Monitor neutrophils, platelets, and liver enzymes 4-8 weeks after starting therapy and every 3 months thereafter, adjusting treatment as needed. Lipid levels, including cholesterol and triglycerides, may increase and should be assessed 4-8 weeks after initiation, with management per clinical guidelines. A similar pattern is observed in PJIA and SJIA, requiring specific monitoring intervals for these populations. Refer to Dosage and Administration for modifications based on test results.

Immunosuppression. The effect of tocilizumab products on malignancy development is unknown, though malignancies were observed in clinical studies. As an immunosuppressant, AVTOZMA may increase the risk of malignancies.

Hypersensitivity Reactions, Including Anaphylaxis. Hypersensitivity reactions, including anaphylaxis and fatal events, have been reported with tocilizumab products. Anaphylaxis requiring discontinuation occurred in 0.1% to 0.7% of trial patients, with postmarketing cases reported at various doses, with or without premedication, and as early as the first infusion. AVTOZMA intravenous infusions must be administered by healthcare professionals equipped to manage anaphylaxis. For subcutaneous use, patients must seek immediate medical attention if hypersensitivity symptoms occur. Discontinue AVTOZMA permanently if anaphylaxis or other hypersensitivity reaction occurs. Do not use in patients with known hypersensitivity to tocilizumab products.

Demyelinating Disorders. The impact of tocilizumab on demyelinating disorders is unknown, but rare cases like multiple sclerosis and polyneuropathy were reported in RA studies. Monitor for symptoms and use caution in patients with preexisting or recent demyelinating disorders.

Active Hepatic Disease and Hepatic Impairment. Treatment with AVTOZMA is not recommended.

Live Vaccines. Avoid concurrent use of live vaccines with AVTOZMA, as clinical safety and secondary transmission risk are unknown. Follow guidelines on timing between live vaccines and AVTOZMA.

Adverse Reactions reported in ≥5% of tocilizumab-treated patients include upper respiratory tract infections, nasopharyngitis, headache, hypertension, increased ALT, and injection site reactions.

Please see full Prescribing Information, including BOXED WARNING.

INDICATIONS

AVTOZMA® (tocilizumab-anoh) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of:

  • Rheumatoid Arthritis (RA): Adult patients with moderately to severely active RA who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs).
  • Giant Cell Arteritis (GCA): Adult patients with GCA.
  • Polyarticular Juvenile Idiopathic Arthritis (PJIA): Patients 2+ years old with active PJIA.
  • Systemic Juvenile Idiopathic Arthritis (SJIA): Patients 2+ years old with active SJIA.
  • Cytokine Release Syndrome (CRS): 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
  • Coronavirus Disease 2019 (COVID-19): Hospitalized adult patients with COVID-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

INDICATIONS

AVTOZMA® (tocilizumab-anoh) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of:

  • Rheumatoid Arthritis (RA): Adult patients with moderately to severely active RA who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs).
  • Giant Cell Arteritis (GCA): Adult patients with GCA.
  • Polyarticular Juvenile Idiopathic Arthritis (PJIA): Patients 2+ years old with active PJIA.
  • Systemic Juvenile Idiopathic Arthritis (SJIA): Patients 2+ years old with active SJIA.
  • Cytokine Release Syndrome (CRS): 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
  • Coronavirus Disease 2019 (COVID-19): Hospitalized adult patients with COVID-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

IMPORTANT SAFETY INFORMATION

WARNING: RISK OF SERIOUS INFECTIONS

Patients treated with tocilizumab products including AVTOZMA are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

If a serious infection develops, interrupt AVTOZMA 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 AVTOZMA use and during therapy. Treatment for latent infection should be initiated prior to AVTOZMA 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.

The risks and benefits of treatment with AVTOZMA should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.

Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with AVTOZMA, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.

Contraindications: Known hypersensitivity to tocilizumab products.

Serious Infections. Serious and sometimes fatal infections, including bacterial, mycobacterial, invasive fungal, viral, and opportunistic infections, have been reported with tocilizumab products, including AVTOZMA. Common serious infections include pneumonia, urinary tract infections, cellulitis, herpes zoster, and sepsis, while opportunistic infections such as tuberculosis and cryptococcus have also occurred. Patients with chronic or recurrent infections, tuberculosis exposure, or underlying conditions predisposing to infections should have the risks and benefits of AVTOZMA carefully evaluated. Monitor patients closely during and after treatment for signs of infection, and discontinue AVTOZMA if a serious infection develops, initiating appropriate antimicrobial therapy as needed.

Gastrointestinal (GI) Perforation. Gastrointestinal perforation events, primarily associated with diverticulitis, have been reported in clinical trials of tocilizumab. Use AVTOZMA cautiously in patients at increased risk for gastrointestinal perforation. Promptly evaluate any patient experiencing new abdominal symptoms to ensure early detection and management of this condition.

Hepatotoxicity. Serious hepatic injury, including cases of liver transplant and death, has occurred with tocilizumab products, with onset ranging from months to years. Some cases involved marked transaminase elevations (>5x ULN), while others presented with mild elevations and symptoms of liver dysfunction. Risk is higher with hepatotoxic drugs like methotrexate. Baseline and regular liver tests are required for RA, GCA, PJIA, and SJIA patients, with specific monitoring intervals based on the condition. Do not initiate AVTOZMA if ALT or AST >1.5x ULN (RA/GCA) or >10x ULN (COVID-19), and discontinue if ALT or AST >5x ULN. Evaluate symptoms of liver injury promptly, and only restart treatment if liver test abnormalities are resolved and attributed to another cause.

Changes in Laboratory Parameters. Treatment with tocilizumab products, including AVTOZMA, has been associated with neutropenia, thrombocytopenia, elevated liver enzymes, and lipid abnormalities. Infections are uncommon with treatment-related neutropenia, but AVTOZMA should not be initiated in RA or GCA patients with ANC <2000/mm³ or platelet counts <100,000/mm³, and treatment is not recommended if ANC drops below 500/mm³ or platelets below 50,000/mm³. For COVID-19 patients, AVTOZMA is not recommended with ANC <1000/mm³ or platelets <50,000/mm³. Monitor neutrophils, platelets, and liver enzymes 4-8 weeks after starting therapy and every 3 months thereafter, adjusting treatment as needed. Lipid levels, including cholesterol and triglycerides, may increase and should be assessed 4-8 weeks after initiation, with management per clinical guidelines. A similar pattern is observed in PJIA and SJIA, requiring specific monitoring intervals for these populations. Refer to Dosage and Administration for modifications based on test results.

Immunosuppression. The effect of tocilizumab products on malignancy development is unknown, though malignancies were observed in clinical studies. As an immunosuppressant, AVTOZMA may increase the risk of malignancies.

Hypersensitivity Reactions, Including Anaphylaxis. Hypersensitivity reactions, including anaphylaxis and fatal events, have been reported with tocilizumab products. Anaphylaxis requiring discontinuation occurred in 0.1% to 0.7% of trial patients, with postmarketing cases reported at various doses, with or without premedication, and as early as the first infusion. AVTOZMA intravenous infusions must be administered by healthcare professionals equipped to manage anaphylaxis. For subcutaneous use, patients must seek immediate medical attention if hypersensitivity symptoms occur. Discontinue AVTOZMA permanently if anaphylaxis or other hypersensitivity reaction occurs. Do not use in patients with known hypersensitivity to tocilizumab products.

Demyelinating Disorders. The impact of tocilizumab on demyelinating disorders is unknown, but rare cases like multiple sclerosis and polyneuropathy were reported in RA studies. Monitor for symptoms and use caution in patients with preexisting or recent demyelinating disorders.

Active Hepatic Disease and Hepatic Impairment. Treatment with AVTOZMA is not recommended.

Live Vaccines. Avoid concurrent use of live vaccines with AVTOZMA, as clinical safety and secondary transmission risk are unknown. Follow guidelines on timing between live vaccines and AVTOZMA.

Adverse Reactions reported in ≥5% of tocilizumab-treated patients include upper respiratory tract infections, nasopharyngitis, headache, hypertension, increased ALT, and injection site reactions.

Please see full Prescribing Information, including BOXED WARNING.

INDICATIONS

AVTOZMA® (tocilizumab-anoh) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of:

  • Rheumatoid Arthritis (RA): Adult patients with moderately to severely active RA who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs).
  • Giant Cell Arteritis (GCA): Adult patients with GCA.
  • Polyarticular Juvenile Idiopathic Arthritis (PJIA): Patients 2+ years old with active PJIA.
  • Systemic Juvenile Idiopathic Arthritis (SJIA): Patients 2+ years old with active SJIA.
  • Cytokine Release Syndrome (CRS): 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
  • Coronavirus Disease 2019 (COVID-19): Hospitalized adult patients with COVID-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).