Steqeyma, an autoimmune disease treatment. [Celltrion]
Steqeyma, an autoimmune disease treatment. [Celltrion]

Celltrion announced Friday that it has officially launched the intravenous (IV) formulation of Steqeyma (ustekinumab), its autoimmune disease treatment, in Japan — one of Asia's key pharmaceutical and biotech markets.

The launch comes roughly four months after Japan's Ministry of Health, Labour and Welfare approved the IV formulation in April, marking an unusually swift commercial rollout. The approval also added Crohn's disease as an indication alongside the existing plaque psoriasis and psoriatic arthritis indications, broadening the range of conditions for which physicians can tailor prescriptions based on a patient's disease state and treatment setting.

Steqeyma is currently the only ustekinumab biosimilar on the Japanese market available in both IV and subcutaneous (SC) forms. Patients can begin with IV induction therapy to achieve rapid disease control in the early stages, then transition to SC maintenance therapy for long-term management — giving them both continuity of treatment and greater convenience.

Celltrion's Japanese subsidiary plans to leverage the direct-sales strength of its existing autoimmune product portfolio, which already holds the top biosimilar prescription share in the country, to secure an early foothold with Steqeyma. As of May, Remsima (infliximab) held a 46.9 percent share and Yuflyma (adalimumab) 19.5 percent — each ranking first among biosimilar prescriptions in their respective categories. The company plans to activate its network of local key opinion leaders, including gastroenterologists and pharmacists, to drive prescription growth.

Celltrion also plans to participate in major academic conferences in the second half of the year — including the Japanese Digestive Disease Week and the Japanese Society for Inflammatory Bowel Disease — to communicate Steqeyma's competitive strengths to healthcare professionals. The company aims to use those appearances to lay the commercial groundwork for Remsima SC, scheduled for launch in Japan next year.

The IV formulation launch gives Celltrion the only dual-form (IV and SC) ustekinumab product in Japan, and the company expects to deepen its dominance in the Japanese autoimmune disease biosimilar market by combining that distinction with its proven direct-sales network.

"With the launch of the Steqeyma IV formulation, we now hold both forms, giving us a clear competitive edge over rivals," a Celltrion official said. "We will make full use of the direct-sales infrastructure and network we have built through our existing product lineup to establish Steqeyma quickly and further strengthen our position in Japan's autoimmune disease market."


silverpaper@heraldcorp.com