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Celltrion Wins U.S. Approval for Eye Treatment Biosimilar

Seoul: Celltrion Inc., a leading South Korean biopharmaceutical company, announced that its biosimilar for eye diseases has received approval for sale in the United States. The U.S. Food and Drug Administration (FDA) has approved Eydenzelt, Celltrion's biosimilar referencing Eylea, for the treatment of wet age-related macular degeneration and other ophthalmic conditions, as per the company's press release.

According to Yonhap News Agency, both the Eydenzelt injection and Eydenzelt prefilled syringe (PFS) formulations have received approval. The global market for Eylea, developed in the United States, was valued at 13.33 trillion won (US$9.52 billion) last year, with U.S. sales alone reaching 8.36 trillion won, the company reported.

Celltrion has already secured marketing authorization for Eydenzelt from the European Commission (EC) and Australia. With the latest FDA approval, the company has expanded its global biosimilar portfolio, bringing the total number of approved products to 11.

Celltrion aims to commercialize 22 biosimilars by 2030, targeting the global biosimilar market, which is projected to grow from 138 trillion won this year to 261 trillion won.

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