Celltrion secured U.S. regulatory approval for Aptozuma, its biosimilar version of Roche’s autoimmune treatment Actemra, expanding its footprint in the competitive biosimilar market. The approval covers both injectable and intravenous formulations for multiple conditions, including rheumatoid arthritis and Covid-19.
The South Korean drugmaker aims to tap into a lucrative market where Actemra generated 2.63 billion Swiss francs ($3.1 billion) in global sales last year, with the U.S. accounting for won 2.2932 trillion ($1.6 billion). The approval adds to Celltrion’s growing portfolio as it targets development of 22 biosimilars by 2030.
The company already received domestic approval for Aptozuma in South Korea and expects European authorization following a positive recommendation from medical regulators. The drug works by blocking interleukin-6, a protein that triggers inflammation in the body.
Biosimilars typically launch at lower prices than original drugs, potentially reducing costs for healthcare systems and patients. However, Celltrion faces competition from other drugmakers developing similar products as patents on blockbuster biologics expire.
The approval marks Celltrion’s latest push into the U.S. market, where biosimilar adoption has historically lagged behind Europe due to regulatory and commercial barriers.
