Biopharmaceutical company Celltrion on Friday said its biosimilar for eye diseases has received approval for sale in the US
SEOUL — 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.
"With Eydenzelt demonstrating biosimilarity to its reference product, we believe this approval will mark a significant milestone in the treatment landscape of retinal diseases -- helping physicians broaden their options and improving patient outcomes," Jacob-Nara added.
Eydenzelt (aflibercept-boav) is a vascular endothelial growth factor (VEGF) inhibitor referencing Eylea (aflibercept). Eydenzelt is approved based on a comprehensive data confirming the therapeutic equivalence of Eylea.
In the US, Eydenzelt is indicated for the treatment of patients with neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy (DR).
While Eydenzelt is Celltrion's first FDA-approved biologic product in ophthalmology, the drug maker has already obtained marketing authorisation for Eydenzelt from the European Commission (EC) and Australia, the report said.
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 commercialise 22 biosimilars by 2030, when the global biosimilar market is projected to reach 261 trillion won, up from 138 trillion won this year.