Celltrion said on the 15th that it obtained marketing authorization from New Zealand's Medicines and Medical Devices Safety Authority (MEDSAFE) for the autoimmune disease treatment "Steqeyma (development name CT-P43)."
Steqeyma is a biosimilar (biologic copycat) of Stelara (generic name ustekinumab), an inflammatory autoimmune disease treatment developed by Janssen, a subsidiary of U.S. company Johnson & Johnson (J&J).
Celltrion is securing approvals for Steqeyma starting with Korea and continuing in major countries including Europe, the United States, the United Kingdom, Canada, and Australia, and is proceeding with sequential launches. The company said, "By being approved in New Zealand as the first Stelara biosimilar, we secured "First Mover" status," adding, "We will accelerate our push into the global ustekinumab market."
With this approval, the portfolio of autoimmune disease treatments supplied for sale in Oceania, including Australia and New Zealand, has grown. New Zealand, along with Australia, is actively introducing biosimilar-friendly policies. It also switched the target of government subsidies from the original drug Herceptin to the biosimilar Herzuma.
The company plans to expand its portfolio to broaden the range of patients treated and further strengthen its influence in the autoimmune disease market. Meanwhile, according to IQVIA, a pharmaceutical market research firm, as of 2024 the global market for ustekinumab is estimated at about $21,665,150,000 (about 30 trillion won).