Celltrion Receives US Approval to Market Autoimmune Disease Treatment 'Stekima'

Celltrion announced on the 18th that it has obtained sales approval from the U.S. Food and Drug Administration (FDA) for the biosimilar of 'Stelara(STELARA, generic name ustekinumab)' named 'Stekima.'

Stelara is an autoimmune disease treatment developed by the global pharmaceutical company Janssen. It inhibits the activity of interleukin (IL)-12 and 23, substances related to inflammation, and is prescribed for plaque psoriasis, psoriatic arthritis, Crohn's disease, ulcerative colitis, and more.

Based on the global Phase 3 clinical trial results, Celltrion applied for product approval and obtained approval for all indications held by Stelara.

According to the pharmaceutical market research firm IQVIA, the global ustekinumab market size reached approximately $20.4 billion (26.52 trillion KRW) last year, with the U.S. market accounting for about $15.612 billion (20.2956 trillion KRW), representing 77%. Prior to approval, Celltrion completed a patent agreement with the original drug developer, making it possible to launch Stekima in the U.S. market starting February 2025.

A Celltrion official stated, "With the sales approval of Stekima in the U.S., Celltrion's position in autoimmune disease treatments, where it already shows particular strength in the U.S., is expected to be further strengthened," adding, "With product approval granted in the world's largest pharmaceutical market, the U.S., we plan to quickly complete the remaining commercialization procedures and actively target the ustekinumab market."