Celltrion's autoimmune disease treatment gets approval in Europe

Celltrion, a leading South Korean biopharmaceutical company, has received European Commission approval for Avtozma, its innovative biosimilar treatment for autoimmune diseases. The drug can be used to treat conditions like rheumatoid arthritis and giant cell arteritis in both intravenous and subcutaneous formulations. This approval follows recent FDA authorization and aligns with Celltrion's strategic plan to expand its biosimilar portfolio to 22 products by 2030. The company sees significant market potential, especially given the global ustekinumab market's substantial value of $20.4 billion in 2023.

"The EC approval on Avtozma marks a critical step in our mission to provide affordable healthcare solutions" - Ha Tae-hun, Celltrion SVP

Celltrion, a major South Korean biopharmaceutical firm, on Monday said its new biosimilar for an autoimmune disease treatment has obtained approval from the European Commission (EC).

Key Points

1 Avtozma approved for EU market treating rheumatoid arthritis

2 FDA approval secured last month

3 Part of Celltrion's ambitious biosimilar expansion strategy

4 Targets 22 biosimilar products by 2030

The EC approved Celltrion's Avtozma, a biosimilar to Actemra, in both intravenous and subcutaneous formulations, for sales in the member countries of the European Union, the company said, Yonhap news agency reported.

Avtozma can be used as a treatment for multiple autoimmune diseases, including rheumatoid arthritis and giant cell arteritis.

"The EC approval on Avtozma marks a critical step in Celltrion's mission to provide European healthcare systems with affordable, effective solutions for immunological disorders," Ha Tae-hun, senior vice president in charge of Celltrion's European operations, said in the release.

Avtozma was also approved by the US Food and Drug Administration (FDA) for local sales last month.

The Korean drugmaker aims to commercialise 22 biosimilar products by 2030, up from the current 11. Celltrion had said Avtozma has great sales potential, noting its original drug, Actemra, raised 2.63 billion Swiss francs ($2.89 billion) globally in 2023.

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 in January, Yonhap reported.

The launch in France follows its release in Britain in December and Germany in November. In last August, the drug won the European Commission's (EC) approval 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.

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