Celltrion announced on the 18th that its autoimmune disease treatment drug STEQEYMA has obtained sales approval from the U.S. Food and Drug Administration (FDA).
STEQEYMA is a biosimilar of Stelara (active ingredient ustekinumab) from the global pharmaceutical company Johnson & Johnson. Based on global phase 3 clinical trial results, Celltrion applied for product approval and obtained approval for the full label indications held by the original drug, including plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.
Celltrion plans to officially launch STEQEYMA in the U.S. market in February next year. A company official said, 'We have completed an agreement with the original developer to ensure that STEQEYMA can be launched in the U.S. in February next year before the approval,' and noted, 'We will do our best to accelerate the remaining commercialization process to ensure early market settlement and expansion of market share.'
According to the market research organization IQVIA, the global ustekinumab market size last year was approximately $20.4 billion (about 26.52 trillion won), with the U.S. market accounting for about 77% ($15.61 billion).
Celltrion anticipates that by adding the interleukin (IL) inhibitor STEQEYMA to its existing portfolio of tumor necrosis factor (TNF-α) inhibitors, including Remsima, Jimpendra (Remsima SC's U.S. brand name), and Uplyma, its influence in the local market will be significantly strengthened. Meanwhile, the company plans to secure a portfolio of 11 biosimilars by 2025.