FDA Approved Avtozma for COVID-19 in Young Patients
Children and adults aged 2 and older can now receive this biosimilar treatment for COVID-19 infection.
Updated on Oct. 7, 2026 in Arthritis
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The U.S. Food and Drug Administration has granted approval for Avtozma to treat COVID-19 in patients as young as 2 years old. This expansion broadens the authorized use of the biosimilar, which is already prescribed for certain forms of arthritis.
Why it matters
Expanding the indication for this drug allows a wider range of patients to access treatment for COVID-19. Medical providers are expected to integrate the therapy more frequently into pediatric and emergency medicine departments.
The FDA approval for COVID-19 treatment extends to individuals aged 2 and older, adding to the existing indications for rheumatoid arthritis, giant cell arteritis, and polyarticular juvenile idiopathic arthritis. This follows the drug's initial U.S. authorization granted in January 2025.
The players
U.S. Food and Drug Administration
The federal agency responsible for protecting public health by ensuring the safety and efficacy of human drugs and biological products.
Celltrion
A biopharmaceutical company that develops biosimilar medications and intends to expand the clinical reach of this treatment.
The details
Avtozma functions as a biosimilar to the medication Aktemra. Patients have two delivery options: an intravenous injection administered by clinical staff in a hospital setting, or a subcutaneous injection that is suitable for self-administration.
Timeline
January 2025: Avtozma received initial approval in the United States.
October 7, 2026: The FDA approved the use of Avtozma for COVID-19 patients aged 2 and older.
Health Landscape
The approval of Avtozma as a biosimilar to Aktemra represents a growing trend in the use of alternative biologics to manage both inflammatory conditions and viral infections. This expansion fits within the broader push to provide more treatment options for pediatric populations.
If you or your child are managing conditions like juvenile idiopathic arthritis, talk to your doctor about how new treatment indications for Avtozma may affect your care plan. Clinicians can determine if this medication is an appropriate option based on specific clinical needs.
The takeaway
The expansion of this biosimilar for COVID-19 offers a new pathway for patients as young as 2 years old to access care. Discuss with your physician whether this, or other authorized therapies, aligns with your current health requirements.
Further reading
Learn more about the management of Arthritis treatments and current clinical standards.
Source note: This article includes information reported by 조선일보.
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Should pharmaceutical companies expand the use of approved drugs to younger age groups?
