Celltrion said on the 27th that it received product approvals for OMLYCLO and Eydenzelt from Japan's Ministry of Health, Labour and Welfare. OMLYCLO is a biosimilar of the allergy treatment XOLAIR, and Eydenzelt is a biosimilar of the ophthalmic disease treatment Eylea.
OMLYCLO is the first XOLAIR biosimilar approved in Japan. It was approved for all original indications, including bronchial asthma, chronic spontaneous urticaria, and seasonal allergic rhinitis.
Eydenzelt was approved for ophthalmic indications such as macular degeneration and diabetic macular edema. Macular degeneration is when the macula, located at the center of the retina, ages and vision declines. In severe cases, vision is lost.
The original drugs XOLAIR and Eylea recorded global sales last year of 7.6 trillion won and 8.5 trillion won. A Celltrion official said, "We will work to establish the new products in the market early."
Meanwhile, according to the pharmaceutical market research firm IQVIA, the breast cancer treatment Herzuma recorded a 76% market share in Japan last year. The autoimmune disease treatments Remsima and Yuflyma had market shares of 43% and 17%, respectively.