Synopsis
Celltrion has received FDA approval for Avtozma, a new biosimilar for autoimmune disease treatment, enhancing its immunology portfolio and expanding access to high-quality therapies.Key Takeaways
- Celltrion's Avtozma is approved by the FDA.
- Avtozma treats autoimmune diseases such as rheumatoid arthritis.
- Celltrion aims to commercialize 22 biosimilars by 2030.
- SteQeyma is another biosimilar recently launched in Europe.
- European ustekinumab market valued at $3.1 billion.
Seoul, Jan 31 (NationPress) Celltrion, a prominent biopharmaceutical company from South Korea, announced on Friday that its innovative biosimilar aimed at treating autoimmune diseases has obtained approval from the US Food and Drug Administration (FDA).
The FDA has granted approval for Celltrion's Avtozma, a biosimilar to Actemra, available in both intravenous and subcutaneous forms, as reported by the Yonhap news agency. Avtozma is indicated for multiple autoimmune conditions, including rheumatoid arthritis, giant cell arteritis, and even Covid-19.
Thomas Nusbickel, the chief commercial officer at Celltrion's US division, stated, "This approval marks a strategic enhancement to our immunology portfolio, reinforcing our dedication to providing accessible and high-quality treatment solutions for patients and healthcare professionals."
Celltrion believes that Avtozma holds significant sales potential, citing that its original drug, Actemra, generated 2.63 billion Swiss francs (approximately $2.89 billion) worldwide in 2023. The South Korean pharmaceutical giant has committed to commercializing 22 biosimilar products by 2030.
Previously, Celltrion announced the launch of another treatment for autoimmune diseases in five major European countries. This treatment, SteQeyma, is an ustekinumab biosimilar for various chronic inflammatory conditions.
As per Celltrion, SteQeyma was introduced in France after its rollout in Italy and Spain earlier this month, according to Yonhap.
The introduction in France follows its launch in Britain last month and in Germany in November. The drug received approval from the European Commission (EC) in August for use in biologic therapies related to gastroenterology, dermatology, and rheumatology.
This marked the seventh biosimilar from Celltrion to gain the EC’s approval, joining others like Remsima, Truxima, and Herzuma.
Celltrion aims to broaden the sales of SteQeyma across Europe and plans to launch the product in the US in the future.
Data from healthcare research firm Iqvia indicates that the European ustekinumab market was valued at $3.1 billion in 2023, with the global market size reaching $20.4 billion.
