Celltrion said Monday it would conduct a global phase 3 clinical trial of its Stelara biosimilar (Ustekinumab), CT-P43. The company began to carry out the clinical trial in June and plans to complete the confirmation of CT-P43’s safety and efficacy by the second half of 2022.
Stelara, an IL-12, 23 suppress agent treating autoimmune diseases, such as psoriasis, Crohn’s disease and ulcerative colitis, is a blockbuster drug developed by Johnson & Johnson, recording $6.31 billion in sales last year.
Celltrion plans to commercialize the drug when the patent on its substance material in the U.S and Europe expires in September 2023 and July 2024, respectively.
The company expects to secure a strong and diverse portfolio of autoimmune disease treatments if CT-P43 is commercialized, following the TNF-α (tumor necrosis factor- α), Remsima® (IV, SC) product, and CT-P17 (HUMIRA® biosimilar).
“We will continue to lead the global market by expanding our product lines in autoimmune disease treatments, ranging from TNF-α to interleukin suppress agent,” a Celltrion official said.
“We will successfully complete the CT-P43 clinical trial and continue to supply high-quality biomedicine at a reasonable price.”