Celltrion has achieved a significant regulatory milestone with the approval of Steqeyma, its biosimilar referencing Stelara, by New Zealand's Medicines and Medical Devices Safety Authority (MEDSAFE). The South Korean biopharmaceutical company announced that Steqeyma has become the first Stelara biosimilar to receive approval in New Zealand, positioning the company advantageously in the Oceania region's autoimmune disease market.
Comprehensive Indication Coverage
The MEDSAFE approval encompasses the full spectrum of indications held by the original Stelara in New Zealand, including psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. Both formulations of Steqeyma have received authorization: the standard injection (bottle) and the prefilled syringe (PFS) formulation, providing healthcare providers with flexible administration options for patients.
Strategic Market Positioning
"With this latest approval, Celltrion has secured a 'first-mover' position in New Zealand, one of the key markets in the Oceania region, giving the company an advantage in initial sales," a company official stated. This approval represents part of Celltrion's broader global expansion strategy, building on previous regulatory successes in major markets including Korea, Europe, the United States, the United Kingdom, Canada, and Australia.
The company emphasized its plans to leverage this first-mover advantage to strengthen its competitive position. "We plan to further solidify our position in the market by strengthening our competitiveness and supplying high-quality drugs," the Celltrion official added.
Market Opportunity and Portfolio Expansion
The commercial significance of this approval is underscored by the substantial market opportunity. According to IQVIA data cited by Celltrion, the global market for Stelara was valued at 30.33 trillion won ($21.7 billion) in 2024, highlighting the potential impact of biosimilar competition in this therapeutic area.
This New Zealand approval brings Celltrion's global biosimilar portfolio to 11 approved products. The company has set an ambitious target to commercialize 22 biosimilars by 2030, aligning with projections that the global biosimilar market will reach 261 trillion won by that time, representing substantial growth from the current 138 trillion won market size.
Therapeutic Focus and Future Plans
Celltrion indicated its intention to expand its interleukin (IL) inhibitor portfolio, which includes Steqeyma, across the Oceania region. This strategic focus aims to broaden patient coverage and strengthen the company's influence in the autoimmune disease treatment landscape.
The sequential launch strategy, beginning in Korea and expanding to major global markets, demonstrates Celltrion's systematic approach to international commercialization of its biosimilar products. The New Zealand approval represents another step in this comprehensive global rollout plan for Steqeyma.
