Celltrion gets US FDA approval for new biosimilar for autoimmune disease treatment

Seoul: Celltrion, a major South Korean biopharmaceutical firm, on Friday said its new biosimilar for an autoimmune disease treatment has received approval from the US 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, Yonhap news agency reported. 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 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 commercialise 22 biosimilar products by 2030.

Earlier, the company announced another autoimmune disease treatment by Celltrion has been launched in five major European nations. The treatment – SteQeyma — is an ustekinumab biosimilar treatment for multiple chronic inflammatory diseases.

According to Celltrion, it was released in France, following its launch in Italy and Spain earlier this month, Yonhap reported.

The launch in France follows its release in Britain last month and in Germany in November. The drug won the European Commission’s (EC) approval in August for biologic therapy in gastroenterology, dermatology, and rheumatology indications.

It marked Celltrion’s seventh biosimilar to win the EC’s approval, following Remsima, Truxima, Herzuma, and others.

Celltrion said it plans to expand sales of SteQeyma in Europe and also introduce the product in the US in the future.

According to data from healthcare researcher Iqvia, the European ustekinumab market was valued at $3.1 billion in 2023, with the global market size reaching $20.4 billion.

–IANS