Celltrion has received marketing authorization from the European Commission for SteQeyma (CT-P43), a biosimilar to Stelara (ustekinumab), aimed at treating multiple autoimmune diseases. This approval covers key indications such as plaque psoriasis, psoriatic arthritis, and Crohn’s disease. The decision follows a positive recommendation from the European Medicines Agency’s CHMP in June 2024.
With this latest authorization, Celltrion adds SteQeyma to its growing portfolio of autoimmune treatments, which already includes well-established TNF-α inhibitors like Remsima and Yuflyma. The approval also follows recent regulatory successes for SteQeyma in South Korea and Canada, positioning the company to better compete in the global biosimilar market.
The global market for ustekinumab, the reference product for SteQeyma, was valued at approximately $20.4 billion in 2023, with Europe accounting for around $3.11 billion of that total. Celltrion’s entry into this market with SteQeyma is expected to enhance its competitive stance in the biosimilar industry, offering more treatment options for patients with autoimmune diseases.
