Celltrion announced on the 27th that it has obtained marketing authorization from Japan’s Ministry of Health, Labour and Welfare for two key biosimilars: Omliclo (omalizumab) and Idenzelt (aflibercept). The approvals significantly expand Celltrion’s therapeutic footprint in Japan, stretching from respiratory and allergic treatments to advanced ophthalmic care.
Omliclo has made history as the first Xolair biosimilar approved in Japan, securing a critical first-mover advantage. It received approval for all indications held by the reference product, including bronchial asthma, chronic spontaneous urticaria, and seasonal allergic rhinitis. To enhance patient convenience, the treatment was authorized in two delivery formats: a prefilled syringe and an autoinjector.
The reference drug, Xolair, is a global blockbuster that recorded approximately KRW 7.6 trillion in sales last year. By entering the market ahead of competitors, Celltrion is positioned to capture a significant share of this high-demand segment.
Idenzelt enters the Japanese market with approvals for major ophthalmic indications, including age-related macular degeneration and diabetic macular edema. It will be available in both vial and prefilled-syringe formulations to meet diverse clinical needs.
The reference product, Eylea, is a leading global therapy with sales reaching approximately KRW 8.5 trillion last year. The addition of Idenzelt allows Celltrion to compete in one of the most lucrative areas of the specialty biopharmaceutical market.
Celltrion plans to accelerate the rollout of these new products by utilizing the commercial infrastructure and brand recognition built through its existing portfolio. Products such as Herzuma, Vegzelma, and Remsima have already secured strong market shares in Japan, providing a proven roadmap for these new launches.
"The simultaneous approvals of Omliclo and Idenzelt provide a strategic opportunity to further solidify Celltrion’s presence in the Japanese market," a Celltrion official stated. With these additions, the company continues to transition from a specialized biosimilar manufacturer to a comprehensive provider of diverse therapeutic solutions in the region.
