[Vancouver] In a strategic move to expand its presence and tap into the flourishing North American market, Celltrion has recently filed applications for product licenses for both "STELARA," a potent autoimmune disease treatment, and its biosimilar counterpart, "CT-P43," with the esteemed U.S. Food and Drug Administration (FDA) and Health Canada. These applications encompass all indications covered by the original drug, Stellar, which include various autoimmune conditions like plate-shaped psoriasis, psoriasis arthritis, Crohn's disease, and ulcerative colitis. It's worth noting that Celltrion has already successfully completed the application process for CT-P43's product license with the European Medicines Agency (EMA) and the Ministry of Food and Drug Safety in Korea.
By securing the item license for CT-P43, Celltrion aims to expand its product portfolio to include a range of interleukin inhibitor therapies, further bolstering its competitive edge in the global market for autoimmune disease treatments. The strategic significance lies in the fact that North America stands as the largest Ustekinumab market globally, making the acquisition of the item license a pivotal moment for Celltrion. According to the esteemed pharmaceutical market research firm, IQVIA, the global Ustekinumab market reached a staggering USD 17.77 billion (approx. KRW 23.101 trillion) in 2022, with the North American market capturing more than 80% of the overall market share at USD 14.246 billion (around KRW 18.519.8 billion).
Stellara, the original drug upon which CT-P43 is based, serves as an inhibitor of interleukin (IL) 12 and 23, meticulously developed by Janssen. It has been effectively utilized for the treatment of various autoimmune diseases, including plate-shaped psoriasis, psoriasis arthritis, Crohn's disease, and ulcerative colitis. It's important to note that the material patents for Stellara are expected to expire in the United States in September of this year and in Europe in July 2024, respectively.
An official from Celltrion expressed their enthusiasm, stating, "We are fervently augmenting our standing in the autoimmune disease treatment market by methodically pursuing CT-P43's item license in prominent global markets throughout the first half of this year." This proactive approach by Celltrion signifies its commitment to seizing opportunities and solidifying its position in the thriving realm of autoimmune disease treatments.
