FDA Approved Avtozma for COVID-19 Patients

Regulators cleared the biosimilar drug for treatment in pediatric patients aged two years and older.

Updated on Oct. 7, 2026 in Arthritis

Isometric editorial illustration of a glass pharmaceutical ampoule on a sterile surface, representing FDA approval of a pediatric medication. — The FDA approved Avtozma, a biosimilar medication, for COVID-19 treatment in pediatric patients aged two and older, expanding treatment options for healthcare providers. AI Illustration. Upload story photo >

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Should pharmaceutical companies expand the use of approved drugs to younger age groups?

The U.S. Food and Drug Administration has approved the use of Avtozma to treat COVID-19 in patients aged 2 years and older. The drug serves as a biosimilar to Aktemra and is available as both an intravenous and subcutaneous injection.

Why it matters

This expanded indication allows for a wider patient population to receive the medication. Celltrion, the drug developer, intends to increase usage within pediatric and emergency medicine departments.

Avtozma is currently indicated for rheumatoid arthritis, giant cell arteritis, and polyarticular juvenile idiopathic arthritis. The treatment is administered via intravenous drip in hospitals or through subcutaneous self-injection.

The players

U.S. Food and Drug Administration

The federal agency responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs.

Celltrion

A global biopharmaceutical company that specializes in the research, development, and manufacturing of biosimilar and innovative drugs.

The details

Avtozma functions as a biosimilar to the existing drug Aktemra. The drug is administered either by hospital staff through an intravenous drip or through self-administration for patients using the subcutaneous injection method.

January 2025: Avtozma received initial approval in the United States.
October 7, 2026: The FDA approved Avtozma for COVID-19 patients aged 2 and older.

The Big Picture

The approval of Avtozma as a biosimilar to Aktemra follows the established clinical use of the original medication as a reference point for this class of therapeutic treatment. This expansion marks a continued trend in the market of scaling biosimilar accessibility for diverse conditions.

Patients and caregivers now have additional access to this medication for COVID-19 treatment across a wider age range starting at 2 years old. Families should consult with healthcare providers regarding whether the subcutaneous or intravenous administration method is appropriate.

The takeaway

The FDA authorization provides pediatric patients access to an established treatment protocol for COVID-19. Clinicians and families should discuss the administration requirements of the drug to determine the best care plan for their specific needs.