Seoul, Oct 10 (NationPress) - The South Korean biopharmaceutical firm Celltrion announced on Friday that its biosimilar aimed at treating eye diseases has successfully obtained approval for sale in the United States.

The US Food and Drug Administration (FDA) has granted authorization for Eydenzelt, Celltrion's biosimilar that references Eylea, specifically targeting the treatment of wet age-related macular degeneration and other ophthalmic disorders, as reported in a statement by the company and Yonhap news agency.

Both formulations of Eydenzelt, including the injection and the prefilled syringe (PFS), have received the green light.

The market for Eylea, originally developed in the US, was valued at 13.33 trillion won (approximately US$9.52 billion) last year, with US sales alone amounting to 8.36 trillion won, according to the company's data.

“Access to efficient therapies is crucial for those suffering from retinal diseases. We are delighted to have received FDA approval for Eydenzelt, and we anticipate enhancing the availability of biological treatments across the US,” expressed Dr. Juby Jacob-Nara, Senior Vice President and Chief Medical Officer at Celltrion US.

“Eydenzelt's demonstrated biosimilarity to its reference product signifies a major milestone in the treatment spectrum for retinal diseases, thereby allowing healthcare providers to expand their therapeutic options and improve patient outcomes,” Jacob-Nara noted.

Eydenzelt (aflibercept-boav) acts as a vascular endothelial growth factor (VEGF) inhibitor, referencing Eylea (aflibercept). It has been approved based on extensive data confirming its therapeutic equivalence to Eylea.

In the United States, Eydenzelt is indicated for the treatment of patients suffering from neovascular (wet) age-related macular degeneration (AMD), macular edema post-retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy (DR).

Eydenzelt marks Celltrion's first FDA-approved biologic in the field of ophthalmology. The pharmaceutical company has also secured marketing authorization for Eydenzelt from the European Commission (EC) and Australia, as reported.

With this latest FDA approval, Celltrion has broadened its global biosimilar portfolio, raising the total number of approved products to 11.

The firm aims to commercialize 22 biosimilars by 2030, anticipating that the global biosimilar market will expand to 261 trillion won, up from 138 trillion won this year.