AVTOZMA (TOCILIZUMAB-ANOH): A BIOSIMILAR ADVANCING RHEUMATOID ARTHRITIS CARE

Medically Reviewed by Dr. Sony Sherpa (MBBS)

Avtozma (tocilizumab-anoh) is a newly approved biosimilar to Actemra (tocilizumab), developed by Celltrion. It is designed to treat several autoimmune and inflammatory conditions, including rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA), and COVID-19. The U.S. Food and Drug Administration (FDA) approved Avtozma on January 24, 2025, marking it the third biosimilar of Actemra to receive FDA approval. ​

Prior to Avtozma, the FDA approved two other Actemra biosimilars: Tofidence (tocilizumab-bavi) in September 2023 and Tyenne (tocilizumab-aazg) in March 2024.

The introduction of Avtozma adds to the growing list of biosimilar options for patients, potentially increasing access to effective treatments for various inflammatory conditions.

What is Avtozma (tocilizumab-anoh)?

Avtozma (tocilizumab-anoh) is a biosimilar to tocilizumab, the generic biologic disease-modifying antirheumatic drug (DMARD) used to treat various inflammatory conditions.

Tocilizumab works as an interleukin-6 (IL-6) receptor antagonist. IL-6 is a cytokine that participates in the body's inflammatory response mechanisms. In conditions like RA, IL-6 levels are often elevated, contributing to chronic inflammation and joint damage. By blocking IL-6 receptors, tocilizumab helps reduce inflammation and improve clinical symptoms.

Avtozma is available in two formulations: intravenous (IV) infusion and subcutaneous (SC) injection, allowing for treatment flexibility depending on the patient's needs and healthcare setting.

This medication is often prescribed to patients who have not responded adequately to methotrexate (MTX) or who are intolerant to it. For disease control and joint protection, Avtozma can be used as monotherapy or in combination with conventional DMARDs.

FDA Approval of Avtozma

The Food and Drug Administration’s approval of Avtozma marks a significant step forward in expanding access to biologic treatments for inflammatory diseases.

The FDA’s decision was based on a comprehensive body of evidence, including a Phase III clinical trial that confirmed Avtozma's high similarity to the reference product, Actemra. The data demonstrated no clinically meaningful differences in terms of efficacy, safety, pharmacokinetics, and immunogenicity. These findings affirm Avtozma’s reliability as a biosimilar option in clinical settings, offering patients and providers a cost-effective alternative with comparable therapeutic effects to Actemra.

Conditions Treated by Avtozma

Below are the key indications for which Avtozma is approved as per the FDA and EMA:

Rheumatoid Arthritis (RA) in Adults

Avtozma has proven to be highly effective in managing Rheumatoid Arthritis (RA), particularly for patients who have had an inadequate response to traditional Disease-Modifying Anti-Rheumatic Drugs (DMARDs). RA is a chronic autoimmune disease that starts with inflammation and pain in the joints and eventually leads to joint damage over time.

By targeting the interleukin-6 receptor, Avtozma helps control the inflammation associated with RA. It is approved for both monotherapy and combination therapy with methotrexate or other DMARDs.

Giant Cell Arteritis (GCA) in Adults

Giant Cell Arteritis, a large artery inflammatory condition often affecting the temporal arteries, can lead to serious complications like vision loss or stroke if not treated. Avtozma has shown strong efficacy in treating GCA in adults, helping patients achieve sustained remission and significantly reducing flare frequency.

Avtozma decreases the need for high-dose corticosteroids, providing relief from symptoms such as headache, scalp tenderness, and visual disturbances. Avtozma is typically used in combination with corticosteroids to manage inflammation and prevent disease flare-ups.

Polyarticular Juvenile Idiopathic Arthritis (pJIA) in Patients Aged 2 Years and Older

This form of juvenile arthritis affects five or more joints and can cause significant pain, swelling, and joint damage. Avtozma is approved for the treatment of pJIA in children aged 2 years and older. In pediatric patients, Avtozma has been shown to significantly reduce joint swelling, pain, and inflammation, improving mobility and the overall quality of life for children suffering from this debilitating condition. By targeting the IL-6 receptor, Avtozma helps reduce systemic inflammation and improve joint function, making it an important option for pediatric rheumatologists.

Systemic Juvenile Idiopathic Arthritis (sJIA) in Patients Aged 2 Years and Older

Systemic Juvenile Idiopathic Arthritis is a severe form of juvenile arthritis that not only affects the joints but also leads to systemic symptoms like fever, rash, and inflammation of internal organs. Avtozma has been shown to be highly effective in treating sJIA in children aged 2 years and older.

For pediatric patients with sJIA, Avtozma provides a vital treatment option, reducing the need for steroids and preventing the progression of joint damage.

COVID-19

In response to the COVID-19 pandemic, Avtozma was approved for use in hospitalized adult patients with severe COVID-19 who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). When used in combination with corticosteroids, Avtozma helps reduce the hyperinflammatory response seen in severe COVID-19 cases.

The drug works by inhibiting IL-6 signaling, which is implicated in the cytokine storm that leads to organ damage and respiratory failure. By modulating the immune system, Avtozma has been shown to improve clinical outcomes in these critically ill patients, helping to prevent deterioration and reducing the need for intensive care.

Cytokine Release Syndrome (CRS) Associated with CAR-T Cell Therapy

This indication, while not recognized by the FDA, has been approved by the European Medicines Agency (EMA). Cytokine Release Syndrome (CRS) is a severe inflammatory response that can occur after CAR-T cell therapy, an innovative immunotherapy used to treat certain cancers. CRS can cause life-threatening symptoms such as fever, hypotension, and organ dysfunction. Avtozma has been shown to effectively treat CRS by targeting and reducing the overproduction of cytokines like IL-6, which are central to the inflammatory response in CRS.

By mitigating the systemic inflammation associated with CRS, Avtozma helps reduce the severity of symptoms and improves patient outcomes following CAR-T cell therapy. This use is particularly important in ensuring the safety of patients undergoing immunotherapy for cancer.

Limited Indications Compared to Actemra

While Avtozma is approved for many of the same conditions as Actemra, it is not approved for all of Actemra’s FDA-approved indications. Notably, Avtozma is not approved by the FDA for:

• Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD).
• Cytokine Release Syndrome (CRS).

These limitations are important to consider when choosing between Avtozma and Actemra for patient care.

Dosage and Administration

Avtozma (tocilizumab-anoh) is available in two primary dosage forms to accommodate different patient needs and clinical settings:

• Intravenous (IV) Infusion: Supplied in single-dose vials with strengths typically including 80 mg/4 mL, 200 mg/10 mL, and 400 mg/20 mL. IV infusion is generally administered by a healthcare professional in a clinical setting, especially for conditions requiring precise dosing and monitoring, such as CRS or hospitalized COVID-19 cases.
• Subcutaneous (SC) Injection: Available in prefilled syringes or autoinjectors, commonly in strengths such as 162 mg/0.9 mL. SC injections may be self-administered at home after proper training, depending on the indication. Conditions like RA and GCA often allow for this more convenient option once the patient is stable and trained in the technique.

Treatment dosage, administration route, and frequency are tailored to each patient to ensure optimal therapeutic outcomes and safety, taking into account factors such as the specific condition and the individual patient's weight. For example, RA and GCA in adults may involve fixed dosing schedules, while pediatric indications like sJIA and pJIA require weight-based dosing.

Potential Benefits of Avtozma as a Biosimilar

Avtozma, as a biosimilar to tocilizumab, offers several key advantages that can positively impact both patients and the healthcare system:

• Improved Access to Treatment: Biosimilars are typically introduced at lower costs compared to their reference biologics, helping reduce financial barriers for patients. This makes vital therapies like tocilizumab more accessible to a broader population, especially those who may have previously been unable to afford biologic treatments.
• Healthcare Cost Savings and Sustainability: The availability of biosimilars such as Avtozma encourages market competition, which may contribute to lower treatment costs over time. While pricing dynamics vary by region and payer policies, biosimilars offer a cost-effective alternative to originator biologics, potentially reducing the financial burden on healthcare systems. This can support broader patient access and allow health systems to reallocate resources toward other high-need areas such as preventive care, innovation, and rare disease management.
• Expanded Treatment Options: Avtozma gives healthcare providers and patients another safe and effective option for managing complex autoimmune and inflammatory diseases. With efficacy and safety comparable to Actemra, Avtozma allows for greater flexibility in treatment planning, especially when considering cost, availability, or insurance coverage.

Important Safety Information and Side Effects

Similar to its reference biologic Actemra, Avtozma is associated with important safety considerations and potential side effects that should be carefully reviewed by patients and healthcare providers.

Common Side Effects

Patients taking Avtozma may experience side effects similar to those seen with Actemra, including:

• Infections (e.g., upper respiratory tract infections)
• Elevated liver enzymes
• Hypertension
• Injection site reactions
• Headache

Generally mild to moderate, these side effects require close monitoring.

Warnings and Precautions

Several serious risks may also occur, particularly in susceptible patients or those on combination therapies. These include:

• Gastrointestinal (GI) perforation – especially in patients with a history of diverticulitis.
• Hepatotoxicity – elevated liver enzymes may require dose adjustment or discontinuation.
• Hypersensitivity reactions, including anaphylaxis.
• Neutropenia and thrombocytopenia – decreased white blood cell and platelet counts.
• Serious infections, including tuberculosis, fungal, bacterial, viral, or opportunistic infections.

There is an increased risk of infection and blood disorders when Avtozma is used in combination with other immunosuppressive agents, requiring close monitoring.

Contraindications

• Allergy or hypersensitivity to tocilizumab or any of its components.
• Active, severe infections, including sepsis or tuberculosis.
• Use of live vaccines should be avoided during treatment due to the risk of infection and reduced vaccine effectiveness.

Monitoring and When to Seek Medical Attention

• Consistent monitoring of complete blood count (CBC), liver function tests, and lipid profiles is a necessary part of the treatment process.
• Dose adjustments or temporary discontinuation may be required to manage low platelet count, neutropenia, or elevated liver enzymes.
• Promptly seek medical attention if you observe any signs of infection (e.g., persistent fever, chills), allergic reactions (e.g., rash, dyspnea), or abnormal bleeding or bruising.

Availability Timeline

• Intravenous (IV) Formulation: Expected to be available in the U.S. in August 2025, following a patent settlement agreement with Genentech. ​
• Subcutaneous (SC) Formulation: Celltrion holds a license to market the SC formulation in the U.S., but the specific launch date remains confidential.

This dual-formulation approach provides flexibility in administration, catering to both clinical settings and patient self-administration after appropriate training.​

Conclusion

Avtozma (tocilizumab-anoh) represents a significant advancement in the expanding landscape of biosimilars, offering a highly comparable, cost-effective alternative to the reference biologic, Actemra. With FDA approval for multiple inflammatory and autoimmune conditions - including RA, GCA, pJIA, sJIA, and severe COVID-19 - Avtozma provides patients and clinicians with a flexible, evidence-backed treatment option. While it is not approved for every indication held by Actemra, such as SSc-ILD or CRS from causes other than CAR-T therapy, Avtozma broadens the therapeutic choices available for managing complex chronic diseases.

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