Celltrion announced that it has launched the autoimmune disease treatment “Aptozyma” (ingredient name: tocilizumab) in Japan. Aptozyma has been introduced as the first-mover product in Japan’s tocilizumab market, marking the first biosimilar to enter a market dominated by the original drug “Actemra.”

Following the marketing authorization obtained from Japan’s Ministry of Health, Labour and Welfare (MHLW) in September last year, Aptozyma was officially launched after about seven months. At the time of approval, Celltrion secured all the key indications held by the original product, including rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), Castleman’s disease (CD), and cytokine release syndrome (CRS). Celltrion’s Japanese subsidiary plans to sell the drug through a direct sales model. As a first-mover pharmaceutical product, it is expected to quickly establish itself in the market. As part of its market penetration strategy, prior to the launch of Aptozyma, the company provided medical staff with relevant academic information and introduced the product’s characteristics based on clinical data at the “70th Annual Scientific Meeting of the Japan College of Rheumatology” held in Japan.

Aptozyma is an interleukin (IL) inhibitor that reduces inflammation by suppressing the action of interleukin-6 (IL-6), which is involved in inducing inflammation in the body. It is reported to have recorded global sales of about 2.47 billion Swiss francs (approximately KRW 3.7 trillion) last year. According to market research firm IQVIA, the Japanese tocilizumab market amounted to around USD 337.6 million (approximately KRW 470 billion) as of last year. Celltrion is continuing to achieve stable results in Japan’s autoimmune disease market by leveraging products that were launched earlier. Its flagship autoimmune disease treatments “Remsima” (infliximab) and “Yuflyma” (adalimumab) currently hold market shares of 44% and 19%, respectively, in Japan, maintaining leading positions in prescriptions. In addition, “Steqima” (ustekinumab), launched in August last year, is also continuing to grow. The company plans to strengthen marketing activities targeting local medical institutions by capitalizing on the advantages of its expanded portfolio of four autoimmune disease products.

Celltrion’s autoimmune disease product portfolio in Japan is expected to expand further. “Omlyclo” (omalizumab) obtained marketing authorization in Japan last month and is aiming for launch in the second half of this year. “Remsima SC,” the world’s only subcutaneous infliximab formulation, is also preparing to enter the Japanese market.

Autoimmune diseases require long-term treatment, and various therapeutic options are often used depending on the patient’s condition. Possessing multiple therapies allows more precise and appropriate responses to individual treatment situations and enhances disease expertise. Celltrion plans to strengthen brand competitiveness and maximize its performance in the Japanese market by expanding its autoimmune disease product portfolio.

A Celltrion representative stated, “With the launch of Aptozyma, our autoimmune disease product portfolio in Japan has expanded to a total of four products, and we expect product synergies and business competitiveness to be further reinforced,” adding, “We will leverage the local market experience and sales infrastructure accumulated through the sales of existing products to ensure a stable supply of Aptozyma and to strengthen our market presence in Japan.”

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