Celltrion announced on June 13 that its biosimilar, Stekeyma, has received product approval from South Korea’s Ministry of Food and Drug Safety. This approval enables Stekeyma to be marketed domestically for all indications held by the original drug, Stelara, which includes treatments for plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.
The approval comes one year after Celltrion applied for domestic authorization. Last year, Celltrion settled a final patent dispute with Stelara’s original developer in the U.S., clearing the way for its entry into the world’s largest market for ustekinumab without legal barriers.
Following this domestic approval, Celltrion aims to secure regulatory approvals in major markets, including the U.S. and Europe, where applications have already been submitted. The global market for ustekinumab was valued at approximately $20.32 billion in 2023, according to IQVIA, highlighting the significant financial potential for Stekeyma.
Celltrion plans to bolster its presence in the autoimmune disease treatment sector with a strong portfolio that includes interleukin inhibitors, alongside its existing TNF-α inhibitor products such as Remsima, Remsima SC, and Yuflyma. The company aims to establish a total of 11 biosimilar pipelines by 2025, including recent approvals of Omriclone, Stekeyma, and Idencel, bringing its total number of commercialized and approved products to nine.
Biosimilars like Stekeyma are biologic medical products that are highly similar to already approved reference products, ensuring no significant differences in terms of safety, purity, and potency. These are essential for treating autoimmune conditions effectively and affordably.
Stelara, the original drug, is a monoclonal antibody targeting IL-12 and IL-23, proteins that play key roles in inflammatory processes. The rigorous regulatory approval process overseen by the Ministry of Food and Drug Safety in South Korea ensures the safety and efficacy of new treatments.
Celltrion’s strategic settlement in the U.S. and subsequent plans to leverage domestic approval for global market entry demonstrate its commitment to expanding its product offerings and market presence. This milestone positions Celltrion to significantly impact the global pharmaceutical market, particularly in the treatment of autoimmune diseases.
