Celltrion's Biosimilar for Autoimmune Disease Gains EC Approval
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Synopsis
Celltrion, a leading South Korean biopharmaceutical company, has secured approval from the European Commission for its biosimilar Avtozma, a treatment for autoimmune diseases. This marks a significant achievement in providing affordable healthcare solutions in Europe.
Key Takeaways
- Avtozma has received EU approval for autoimmune disease treatment.
- It is a biosimilar to Actemra, available in IV and subcutaneous forms.
- The approval signifies Celltrion's commitment to affordable healthcare in Europe.
- SteQeyma has also been launched in major European nations.
- The global ustekinumab market is valued at $20.4 billion.
Seoul, Feb 24 (NationPress) Celltrion, a prominent biopharmaceutical company from South Korea, announced on Monday that its latest biosimilar for treating an autoimmune condition has received approval from the European Commission (EC).
The EC has authorized Celltrion's Avtozma, a biosimilar of Actemra, available in both intravenous and subcutaneous forms, for distribution in the EU member states, as reported by Yonhap news agency.
Avtozma is indicated for use in multiple autoimmune diseases, such as rheumatoid arthritis and giant cell arteritis.
Ha Tae-hun, the senior vice president overseeing Celltrion's European operations, stated in a release, "The EC's endorsement of Avtozma represents a significant advancement in Celltrion's goal to deliver cost-effective and efficient solutions for immunological disorders to European healthcare systems."
Last month, Avtozma also gained approval from the U.S. Food and Drug Administration (FDA) for local distribution.
The South Korean pharmaceutical leader aspires to launch 22 biosimilar products by 2030, up from the existing 11. Celltrion highlighted Avtozma's substantial sales potential, noting that its original counterpart, Actemra, generated 2.63 billion Swiss francs (approximately $2.89 billion) in global sales in 2023.
Previously, the company revealed the launch of another autoimmune treatment, SteQeyma, in five key European countries. SteQeyma is an ustekinumab biosimilar for various chronic inflammatory diseases.
As reported, SteQeyma was introduced in France after its earlier launches in Italy and Spain in January, according to Yonhap.
The rollout in France follows its introduction in Britain in December and Germany in November. In August, the drug received the European Commission's (EC) approval for biologic therapies in gastroenterology, dermatology, and rheumatology.
This represents Celltrion's seventh approved biosimilar by the EC, joining the ranks of Remsima, Truxima, Herzuma, among others.
Celltrion plans to broaden the sales of SteQeyma across Europe and aims to introduce the product in the U.S. in the future.
As per data from healthcare research firm Iqvia, the European ustekinumab market was valued at $3.1 billion in 2023, with the global market reaching a size of $20.4 billion.
