Celltrion Wins U.S. FDA Approval for Eye-Disease Biosimilar Eydenzelt | Be Korea-savvy

Celltrion Wins U.S. FDA Approval for Eye-Disease Biosimilar Eydenzelt


This photo shows the sign of South Korea's pharmaceutical giant Celltrion Inc. (Image courtesy of Yonhap)

This photo shows the sign of South Korea’s pharmaceutical giant Celltrion Inc. (Image courtesy of Yonhap)

SEOUL, Oct. 10 (Korea Bizwire) – Celltrion Inc., a leading South Korean biopharmaceutical company, said Friday 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, the company said in a press release.

Both the Eydenzelt injection and Eydenzelt prefilled syringe (PFS) formulations have been approved, it added.

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, according to the company.

Celltrion has already obtained 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 said it aims to commercialize 22 biosimilars by 2030, when the global biosimilar market is projected to reach 261 trillion won, up from 138 trillion won this year.

(Yonhap)

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