Celltrion announced on the 10th that it has received approval from the U.S. Food and Drug Administration (FDA) for its ophthalmic disease treatment 'Eydenzelt (development name CT-P42)'. Approval was obtained for two formulations: vial and prefilled syringe (PFS).

Eydenzelt is a biosimilar to the global blockbuster 'Eylea (active ingredient aflibercept)', which recorded sales of approximately KRW 13,332.2 billion last year. Celltrion demonstrated equivalence to the original through a global Phase 3 clinical trial conducted on 348 patients with diabetic macular edema. Based on this, it secured the full label of indications held by the original product, including neovascular (wet) age-related macular degeneration (wAMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy (DR).

The United States is particularly regarded as the largest market for aflibercept. Approximately 63% (about KRW 8,355.2 billion) of Eylea's global sales last year were generated in the United States. Celltrion had previously obtained approval in South Korea, Europe (EC), and Australia. With this U.S. approval, it has laid the foundation for targeting the world's largest market. Additionally, receiving consecutive approvals in major global markets is expected to have a positive impact on obtaining product approvals in other countries in the future.

The company is also on track to achieve its goals. With this approval, Celltrion has added five products to its U.S. portfolio this year alone. These include Eydenzelt, the autoimmune disease treatment Aptozma, the bone disease treatment Stoboclo-Osenbelt, and the allergy treatment Omriclo. Furthermore, it has successfully established a product lineup of '11 types' in major global markets, which was the target for this year.

A Celltrion representative stated, "With this approval of Eydenzelt, we can more smoothly expand our treatment area and strengthen our market influence in the world's largest pharmaceutical market, the United States," and added, "We will do our best to swiftly complete the commercialization procedures for major U.S. products and supply high-quality biopharmaceuticals to more patients as quickly as possible."

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