Celltrion has expanded the U.S. approval of its biosimilar Avtozma, a version of the autoimmune disease treatment Actemra (tocilizumab), to include pediatric COVID-19 patients.
Celltrion announced on Thursday that the U.S. Food and Drug Administration (FDA) has granted additional approval for Avtozma’s intravenous (IV) formulation to treat COVID-19 in children aged two and older.
This approval extends Avtozma’s COVID-19 treatment from adults to children and adolescents aged two and above. Avtozma is a biosimilar of tocilizumab, which works by inhibiting interleukin-6 (IL-6), a key player in the body’s inflammatory response.
In the U.S., Avtozma is now approved for rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA), and COVID-19.
Celltrion received FDA approval for both subcutaneous (SC) and IV formulations of Avtozma in January last year. The company has since expanded its approval scope, first adding the cytokine release syndrome (CRS) indication for the IV formulation, and now including the pediatric COVID-19 indication.
The IV formulation is primarily administered in hospital settings, with prescriptions mainly coming from general hospitals and specialized medical institutions. Celltrion aims to leverage this new indication to boost Avtozma prescriptions among healthcare professionals treating pediatric patients.
Actemra, the original drug, reported global sales of approximately 2.47 billion CHF (about 2.96 billion USD) last year. IQVIA estimates that the U.S. tocilizumab market was worth around 1.978 billion USD in the same period.
A Celltrion spokesperson stated that this additional indication allows us to offer treatment options for pediatric patients. It plans to enhance our communication with healthcare professionals to drive the expansion of Avtozma prescriptions in the U.S.
Celltrion, founded in 2002, has established itself as a leader in biopharmaceutical production. The company entered the global market with its first biosimilar, Remsima, receiving domestic approval in 2012, followed by European approval in 2013 and FDA approval in 2016. In 2023, Celltrion merged with Celltrion Healthcare to form a unified corporation.
The company continues to expand its product portfolio with new biosimilars and novel drugs. In a move to strengthen its U.S. presence, Celltrion is set to acquire a manufacturing facility in Branchburg, New Jersey, in 2026.
