Celltrion Gets U.S. FDA Approval for New Biosimilar for Autoimmune Disease Treatment | Be Korea-savvy

Celltrion Gets U.S. FDA Approval for New Biosimilar for Autoimmune Disease Treatment


This undated file photo shows the sign of South Korea's pharmaceutical giant Celltrion Inc. (Image courtesy of Yonhap)

This undated file photo shows the sign of South Korea’s pharmaceutical giant Celltrion Inc. (Image courtesy of Yonhap)

SEOUL, Jan. 31 (Korea Bizwire)Celltrion Inc., a major South Korean biopharmaceutical firm, said Friday its new biosimilar for an autoimmune disease treatment has received approval from the U.S. Food and Drug Administration (FDA).

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 U.S., said in a press release.

Celltrion said Avtozma has great sales potential, noting its original drug, Actemra, raised 2.63 billion Swiss francs (US$2.89 billion) globally in 2023.

The Korean drugmaker has vowed to commercialize 22 biosimilar products by 2030.

(Yonhap)

Leave a Reply

Your email address will not be published. Required fields are marked *

You may use these HTML tags and attributes: <a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <strike> <strong>