Celltrion gets US FDA approval for new biosimilar for autoimmune disease treatment
Celltrion Inc., a major South Korean biopharmaceutical firm, said Friday its new biosimilar for an autoimmune disease treatment has received approval from the US Food and Drug Administration.
The FDA approved Celltrion's Avtozma, a biosimilar to Actemra, in both intravenous and subcutaneous formulations, according to the company.
Avtozma can be used as a treatment for multiple autoimmune diseases, including rheumatoid arthritis and giant cell arteritis, as well as COVID-19.
"This approval represents a strategic addition to our immunology portfolio, further strengthening our commitment to delivering accessible and high-quality treatment options for patients and healthcare providers," Thomas Nusbickel, chief commercial officer at Celltrion's branch in the US, said in a press release.
Celltrion said Avtozma has great sales potential, noting its original drug, Actemra, raised 2.63 billion Swiss francs ($2.89 billion) globally in 2023.
The Korean drugmaker has vowed to commercialize 22 biosimilar products by 2030. (Yonhap)
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