Seoul: Celltrion Inc., a leading South Korean biopharmaceutical company, announced the launch of its biosimilar Avtozma for treating autoimmune diseases in the United States. The company highlighted that the intravenous (IV) formulation of Avtozma is offered at a wholesale acquisition cost 35 percent lower than that of the reference drug, Actemra, in the U.S. market.

According to Yonhap News Agency, Celltrion received approval from the U.S. Food and Drug Administration (FDA) in January for both the IV and subcutaneous (SC) formulations of Avtozma. The company expressed plans to introduce the SC version of the biosimilar in the U.S. "in the near future."

Thomas Nusbickel, chief commercial officer of Celltrion USA, emphasized the company's commitment to providing access to treatment options for serious immune-mediated diseases while supporting the sustainability of the U.S. healthcare system. The global market for Actemra, developed by Switzerland's Roche, was valued at 4.5 trillion won (US$3.14 billion) last year, with U.S. sales accounting for 2.26 trillion won, according to the company.

In the first half of this year, Celltrion reported a net profit of 171.6 billion won on sales of 1.8 trillion won. The Korean drugmaker aims to achieve 5 trillion won in annual sales this year, reflecting a 40 percent increase from a record 3.56 trillion won in 2024. The company has expanded its global biosimilar portfolio, increasing the number of approved products from six to 11, all sanctioned by the FDA.

Celltrion's strategic plans include the commercialization of 22 biosimilars by 2030, aligning with projections of the global biosimilar market growing to 261 trillion won from 138 trillion won this year.