Seoul, Oct 10 || South Korean biopharmaceutical company Celltrion on Friday said its biosimilar for eye diseases has received approval for sale in the US.
The US 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 statement, Yonhap news agency reported.
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 the US sales alone reaching 8.36 trillion won, according to the company.
"Timely access to effective therapies is essential for individuals affected by retinal diseases. We are proud to have Eydenzelt approved by the FDA, and we look forward to expanding the availability and access of biological treatments across the US," said Dr Juby Jacob-Nara, Senior Vice President and Chief Medical Officer at Celltrion US.