Celltrion(068270) said on the 21st that it launched the intravenous (IV) formulation of the autoimmune disease treatment "Steqeyma" (ustekinumab) in Japan. With the addition of the IV formulation to the existing subcutaneous (SC) formulation, the company plans to accelerate prescription expansion in Japan's autoimmune disease market.
Celltrion completed the local launch in Japan about four months after receiving marketing approval for the Steqeyma IV formulation from the Ministry of Health, Labour and Welfare in April.
Steqeyma is a biosimilar of "Stelara," an inflammatory autoimmune disease treatment developed by Janssen, a subsidiary of Johnson & Johnson (J&J). The existing SC formulation has been used to treat psoriasis and psoriatic arthritis, and with this IV formulation approval, Crohn's disease (CD) has been added as an indication. Accordingly, patients can choose between IV and SC formulations depending on disease type and condition and the administration setting.
Celltrion's Japan subsidiary plans to use the sales network and healthcare professional network it has built through sales of existing autoimmune disease treatments, including "Remsima" (Infliximab) and "Yuflyma" (adalimumab), to help Steqeyma gain a foothold in the market. In particular, it will actively use networks with key stakeholders, such as gastroenterologists and pharmacists, to drive prescription growth.
The market clout of the existing product lineup is also expected to help expand prescriptions for Steqeyma. As of May, the market shares in Japan for Remsima and Yuflyma were 46.9% and 19.5%, respectively, with both products maintaining the No. 1 prescription position among biosimilars.
Celltrion expects that expanding its autoimmune disease treatment portfolio will also strengthen marketing synergies with existing products.
Having both IV and SC formulations is also a differentiator for Steqeyma. Patients can use both by receiving initial treatment with the IV formulation and then continuing maintenance therapy with the SC formulation. Selecting a formulation based on disease stage and patient condition can improve treatment convenience and prescription flexibility, the company said.
Among ustekinumab biosimilars currently available in Japan, Steqeyma is the only product that offers both IV and SC formulations.
Celltrion's Japan subsidiary also plans to take part in major conferences in the second half, including the Japan Digestive Disease Week (JDDW) and the Japanese Society for Inflammatory Bowel Diseases (JSIBD), to promote Steqeyma's product competitiveness to healthcare professionals. Through this, it aims to raise product awareness and preference and translate that into actual prescription growth.
In addition, it will strengthen networks with key healthcare professionals and pharmacists and use them as a foundation for sales in Japan of "Remsima SC," slated for launch next year.
A Celltrion official said, "With the launch of the Steqeyma IV formulation, we now have two different formulations, giving us a differentiated edge over competitors, and we expect Japanese healthcare professionals and patients to prefer it even more," adding, "We will actively use the human networks we have built through sales of existing products to ensure Steqeyma's early market establishment, and through this, further raise Celltrion's influence in Japan's autoimmune disease market."