On Aug. 31, Celltrion announced it has completed the product approval application for its autoimmune disease therapeutic “CT-P43,” a biosimilar of STELARA (ustekinumab), to Australia’s Therapeutic Goods Administration (TGA).
Celltrion applied for CT-P43’s product approval in Australia for all indications held by the original medicine, STELARA, including plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. Previously, Celltrion completed similar applications with the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and Korea’s Food and Drug Safety Administration.
Since 2015, Celltrion has been expanding its footprint in the Oceania market by obtaining approvals for major products such as Remsima for autoimmune diseases, Herzuma for breast and stomach cancer, Truxima for blood cancer, and Yuflyma for autoimmune diseases. The approval of CT-P43 is expected to further strengthen their market influence.
STELARA, the original drug of CT-P43 developed by Janssen, is an inhibitor of interleukins (IL)-12 and 23 and is used to treat autoimmune diseases like plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.