South Korean biopharmaceutical firm Celltrion announced Monday that it has received the European Commission’s final approval for Steqeyma, a Stelara (ustekinumab) biosimilar used to treat various autoimmune conditions.
Steqeyma, or CT-P43, has been approved for use in all indications of reference product Stelara, including plaque psoriasis, psoriatic arthritis and Crohn's disease, following recent approvals in Korea and Canada in June and July, respectively.
According to market research firm IQVIA, the global market for ustekinumab was valued at approximately $20.4 billion last year, with Europe accounting for about $3.15 billion of the total.
The European endorsement comes two months after Steqeyma received a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use.
Celltrion views the recent approval as a significant opportunity to strengthen its position in the autoimmune disease market, complementing its existing portfolio of TNF-α inhibitors, including Remsima, Remsima SC (known as "Zymfentra" in the US) and Yuflyma.
“Steqeyma’s approval positions Celltrion to swiftly enter the global autoimmune disease market and expand treatment options for patients,” a Celltrion official said.
“We are focused on launching Steqeyma in key markets and advancing our pipeline to further solidify our market leadership.”
Currently, Celltrion is progressing with other biosimilars, including CT-P47, an Actemra biosimilar; CT-P53, an Ocrevus biosimilar and CT-P55, a Cosentyx biosimilar.
The company aims to secure approval for 11 additional biosimilars by 2025 and is also developing treatments for cancer, bone diseases and eye conditions.
