Celltrion announced Friday that it has received product approval from the Japanese Ministry of Health, Labor and Welfare for Omlyclo, a biosimilar of the allergic disease treatment Xolair (omalizumab), and Eydenzelt, a biosimilar of the ophthalmic disease treatment Eylea (aflibercept).
“This approval provides an opportunity to further strengthen our presence in the Japanese pharmaceutical market,” stated a Celltrion official. “Building on the success of our existing portfolio, we are committed to facilitating the rapid adoption of these new biosimilars.”
Omlyclo distinguishes itself as the first Xolair biosimilar approved in Japan. The approval encompasses all indications held by the originator drug, including bronchial asthma, idiopathic chronic urticaria, and seasonal allergic rhinitis, reinforcing Celltrion’s commitment to offering cost-effective alternatives for allergy sufferers.
Eydenzelt enters the market with approvals for key ophthalmic conditions such as macular degeneration and diabetic macular edema. Offering both vial and prefilled syringe formulations, Eydenzelt is designed to meet the diverse needs of various medical settings and patient preferences.
“Leveraging the strong performance of our established biosimilars, we plan to accelerate the launch of this newly approved product lineup and expand our market share in Japan,” Celltrion emphasized.
According to IQVIA and local data, Celltrion’s Herceptin biosimilar, for breast cancer treatment, holds a 76 percent market share in Japan, solidifying its position as the leading trastuzumab biosimilar for 4.5 years. Furthermore, Begzelma is a market leader with 58 percent market share.
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