Celltrion Receives Approval for Autoimmune Disease Treatment 'Stekima' in New Zealand

Strengthening Competitiveness in the Oceania Market

Celltrion announced on October 15 that it has received product approval from the New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE) for 'Stekima,' a biosimilar of 'Stelara' (active ingredient: ustekinumab), a treatment for autoimmune diseases.

Stekima. Celltrion

With this approval, Stekima has secured authorization for all indications held by the original drug in New Zealand, including psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. The approved formulations are injection (vial) and pre-filled syringe (PFS).

Starting with Korea, Celltrion has been obtaining approvals for Stekima from major global markets such as Europe, the United States, the United Kingdom, Canada, and Australia, and is proceeding with sequential launches. By becoming the first Stelara biosimilar to receive approval in New Zealand, Celltrion has established its 'first-mover' status, which is expected to accelerate its entry into the global ustekinumab market.

The company plans to further strengthen its influence in the autoimmune disease market by expanding its portfolio in the Oceania region, including Australia and New Zealand, to include interleukin (IL) inhibitors such as Stekima.

According to the pharmaceutical market research firm IQVIA, the global ustekinumab market is estimated to be worth approximately 21.66515 billion dollars (about 30.3312 trillion won) as of 2024.

New Zealand, like Australia, is actively adopting biosimilar-friendly policies. In 2023, the government shifted subsidy support for trastuzumab from the original 'Herceptin' to the biosimilar 'Herzuma,' thereby expanding patient access to medical care based on equivalent therapeutic effects.

A Celltrion representative stated, "With the approval of Stekima, we have secured first-mover status in New Zealand, one of the major countries in Oceania, allowing us to gain an early advantage in the initial market launch. We plan to further solidify our market position through continuous competitiveness enhancement and the supply of high-quality pharmaceuticals."