The approval of biosimilar medicines continues to transform the treatment landscape for autoimmune disorders, making advanced biologic therapies more accessible to patients worldwide. One of the newest additions is Avtozma, a biosimilar version of Actemra developed by Celltrion.

In January 2025, the U.S. FDA approved Avtozma for several serious inflammatory and autoimmune conditions, including rheumatoid arthritis, giant cell arteritis, juvenile idiopathic arthritis, and severe COVID-19 complications. The approval offers physicians and patients another effective biologic therapy option while potentially lowering treatment costs.

What Is Avtozma (Tocilizumab-Anoh)?

Avtozma is a biosimilar medicine containing tocilizumab, a biologic drug that targets inflammation by blocking the interleukin-6 (IL-6) receptor.

IL-6 is an important immune system protein involved in inflammation. In autoimmune diseases such as rheumatoid arthritis, excessive IL-6 activity contributes to joint pain, swelling, stiffness, and long-term tissue damage. By preventing IL-6 from attaching to its receptors, Avtozma helps reduce inflammation and improve symptoms.

Like the original biologic Actemra, Avtozma belongs to the class of medications known as biologic DMARDs (Disease-Modifying Antirheumatic Drugs).

The medication is available in two forms:

• Intravenous (IV) infusion
• Subcutaneous (SC) injection

This allows healthcare providers to tailor treatment according to the patient’s condition, severity, and convenience.

FDA Approval and Biosimilar Status

The FDA officially approved Avtozma on January 24, 2025. It became the third FDA-approved biosimilar to Actemra.

Earlier approved tocilizumab biosimilars include:

• Tofidence
• Tyenne

The approval was supported by extensive analytical testing, pharmacokinetic studies, and Phase III clinical trial data showing that Avtozma has no clinically meaningful differences from Actemra in terms of:

• Effectiveness
• Safety
• Immunogenicity
• Quality
• Pharmacokinetics

This means patients can expect similar therapeutic benefits and safety outcomes compared to the reference biologic.

Conditions Treated by Avtozma

1. Rheumatoid Arthritis (RA)

Rheumatoid Arthritis is a chronic autoimmune disorder that primarily attacks the joints. Persistent inflammation can eventually cause joint destruction and disability.

Avtozma is approved for adults with moderate to severe RA who have not responded adequately to methotrexate or other conventional DMARDs.

Benefits in RA may include:

• Reduced joint inflammation
• Less pain and stiffness
• Improved physical function
• Slower progression of joint damage

The drug may be used alone or together with methotrexate.

2. Giant Cell Arteritis (GCA)

Giant Cell Arteritis is a serious inflammatory disease affecting large arteries, especially around the temples and scalp.

Untreated GCA can lead to complications such as:

• Vision loss
• Stroke
• Severe headaches

Avtozma helps reduce vascular inflammation and may decrease dependence on long-term corticosteroid therapy.

3. Polyarticular Juvenile Idiopathic Arthritis (pJIA)

Polyarticular Juvenile Idiopathic Arthritis affects multiple joints in children and can significantly impact growth, mobility, and quality of life.

Avtozma is approved for children aged 2 years and older and may help:

• Reduce joint swelling
• Improve mobility
• Control chronic inflammation
• Prevent long-term joint complications

4. Systemic Juvenile Idiopathic Arthritis (sJIA)

Systemic Juvenile Idiopathic Arthritis is a severe inflammatory condition that affects not only the joints but also the entire body.

Common symptoms include:

• Recurring fever
• Skin rash
• Fatigue
• Organ inflammation

Avtozma helps control systemic inflammation and may reduce the need for high-dose steroids in children.

5. Severe COVID-19

During the COVID-19 pandemic, IL-6 inhibitors gained attention for their ability to suppress the dangerous inflammatory response known as a cytokine storm.

Avtozma is approved for hospitalized adults with severe COVID-19 requiring:

• Supplemental oxygen
• Mechanical ventilation
• ECMO support

When combined with corticosteroids, the drug may improve outcomes by reducing excessive immune activation.

EMA Approval for Cytokine Release Syndrome (CRS)

The European Medicines Agency has also approved Avtozma for treating Cytokine Release Syndrome associated with CAR-T cell therapy.

CRS can occur after cancer immunotherapy and may cause:

• High fever
• Low blood pressure
• Organ dysfunction
• Respiratory distress

By blocking IL-6 activity, Avtozma helps control the severe inflammatory reaction.

Conditions Not Approved for Avtozma in the U.S.

Although Avtozma shares many indications with Actemra, it does not currently hold FDA approval for:

• Systemic sclerosis-associated interstitial lung disease (SSc-ILD)
• Cytokine release syndrome (CRS) in the United States

These differences are important when selecting the most appropriate biologic therapy.

Dosage Forms and Administration

Avtozma is offered in both IV infusion and SC injection formats.

Intravenous Infusion

Available strengths commonly include:

• 80 mg/4 mL
• 200 mg/10 mL
• 400 mg/20 mL

IV administration is usually performed in a hospital or infusion center.

Subcutaneous Injection

SC injections are typically available as:

• Prefilled syringes
• Autoinjectors
• 162 mg/0.9 mL dosage strength

Many patients can self-administer the medication at home after receiving proper training.

Advantages of Avtozma as a Biosimilar

Better Treatment Accessibility

Biologic medications are often expensive. Biosimilars like Avtozma may help lower treatment costs, making advanced therapies more affordable for patients.

Increased Competition in the Biologic Market

The availability of additional biosimilars may encourage price competition, potentially reducing healthcare spending over time.

More Treatment Flexibility

Having multiple biosimilar options gives physicians greater flexibility when considering:

• Insurance coverage
• Drug availability
• Patient preference
• Treatment planning

Possible Side Effects of Avtozma

Like other IL-6 inhibitors, Avtozma may cause side effects ranging from mild to serious.

Common Side Effects

Patients may experience:

• Upper respiratory infections
• Injection site reactions
• Headache
• High blood pressure
• Elevated liver enzymes

Serious Safety Warnings

More severe complications can include:

• Serious infections
• Tuberculosis
• Liver injury
• Gastrointestinal perforation
• Allergic reactions
• Low white blood cell count
• Low platelet count

Patients receiving immunosuppressive medications alongside Avtozma may face a higher risk of infection.

Important Monitoring During Treatment

Healthcare providers usually monitor patients regularly through:

• Complete blood count (CBC)
• Liver function tests
• Lipid profile testing

Medical attention should be sought immediately if symptoms such as fever, breathing difficulty, unusual bruising, or severe allergic reactions occur.

Availability in the United States

According to current timelines:

• The IV formulation is expected to launch in the U.S. in August 2025.
• The launch date for the SC formulation has not yet been publicly announced.

Final Thoughts

Avtozma represents an important development in the growing field of biosimilar medicines. By offering a highly comparable alternative to Actemra, it expands access to advanced biologic therapy for patients living with chronic inflammatory diseases.

Its approval for rheumatoid arthritis, giant cell arteritis, juvenile idiopathic arthritis, and severe COVID-19 highlights its versatility as an IL-6 inhibitor. Although certain indications remain exclusive to the original biologic, Avtozma still provides healthcare professionals with another effective treatment option that may improve affordability and access for many patients.