Celltrion has announced that its eye disease treatment, Eydenzelt, has received approval from the U.S. Food and Drug Administration (FDA), granting the company access to a significant market valued at approximately $6 billion. Eydenzelt is a biosimilar to Eylea, developed by Regeneron Pharmaceuticals, which generated global sales of $9.52 billion last year, with $5.97 billion from the U.S. alone. In a Phase 3 clinical trial involving 348 patients, Celltrion demonstrated that Eydenzelt is equivalent to Eylea in terms of efficacy and safety. The FDA approval encompasses all adult indications held by the reference drug, including neovascular age-related macular degeneration and macular edema following retinal vein occlusion. Celltrion has already secured regulatory approvals for Eydenzelt in several major markets, including Korea, Europe, and Australia. This approval marks Celltrion’s fifth biologic to obtain U.S. approval this year, following treatments for autoimmune diseases, bone disorders, and allergies. The company plans to expedite the commercialization process in the U.S. to ensure the timely availability of high-quality biologics to patients. (ICE SEOUL)

Fonte notizia: The Korea Times