Celltrion's tocilizumab biosimilar, Aptozma, has been approved for use as a treatment for pediatric COVID-19 in the United States. On October 7, Celltrion announced that the U.S. Food and Drug Administration (FDA) has granted additional approval for the intravenous (IV) formulation of Aptozma for treating COVID-19 in children aged 2 and older. This expands the patient population eligible for Aptozma treatment from adults to include children and adolescents.
Aptozma is a biosimilar of Roche's autoimmune disease treatment, Actemra. It works by blocking the action of interleukin-6 (IL-6), which triggers inflammatory responses in the body. Celltrion received approval for both the IV and subcutaneous (SC) formulations of Aptozma in the U.S. in January 2022. Since then, it has added indications for cytokine release syndrome (CRS) for the IV formulation and now for pediatric COVID-19. Aptozma is also approved in the U.S. for rheumatoid arthritis, giant cell arteritis, and polyarticular and systemic juvenile idiopathic arthritis.
With the expansion of indications, Celltrion is expected to gain momentum in the market. The original Actemra generated approximately 2.47 billion Swiss francs (about $2.7 billion) in global sales last year. Market research firm IQVIA estimated the U.S. tocilizumab market size at around $1.978 billion (approximately 2.77 trillion won) last year.
Since the IV formulation is administered directly by healthcare professionals in hospitals, prescriptions are likely to be concentrated in general hospitals and specialized medical institutions. Celltrion plans to increase prescriptions in the U.S. by expanding its connections with healthcare providers treating pediatric patients.
A Celltrion representative stated, "With this additional indication, we can provide new treatment options for pediatric patients. We will strengthen communication with healthcare professionals to promote the expansion of Aptozma prescriptions in the U.S."
Since launching its first biosimilar, Remsima, in 2012, Celltrion has been expanding its product lineup with subsequent biosimilars and new drugs. The company has also strengthened its local production base by acquiring a manufacturing facility in Branchburg, New Jersey.
Earlier this year, Celltrion set a target of 5.3 trillion won in annual revenue and 1.8 trillion won in operating profit, expecting to exceed these goals.
* This article has been translated by AI.
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