Celltrion Secures U.S. Approval for Eylea Biosimilar 'Eydenzelt'

Full-scale Entry into the $13 Billion Global Market

Celltrion announced on October 10 that it has received approval from the U.S. Food and Drug Administration (FDA) for the registration of “Eydenzelt” (development name: CT-P42), a biosimilar of the ophthalmic disease treatment “Eylea” (active ingredient: aflibercept). The approved formulations are Eydenzelt Injection and Eydenzelt Prefilled Syringe (PFS).

Celltrion previously demonstrated the equivalence of CT-P42 to the original drug in a global Phase 3 clinical trial involving 348 patients with diabetic macular edema. Based on these results, Celltrion obtained approval for all indications held by the original drug for adults in the United States, including neovascular (wet) age-related macular degeneration, macular edema secondary to retinal vein occlusion, diabetic macular edema, and diabetic retinopathy.

The original drug, Eylea, achieved blockbuster status last year with global sales of $9.523 billion (approximately 13.3322 trillion KRW). In the United States alone, the world’s largest pharmaceutical market, it recorded $5.968 billion (about 8.3552 trillion KRW) in sales last year.

Celltrion is accelerating its global market expansion by consecutively obtaining approval for Eydenzelt in major markets such as South Korea, Europe (EC), Australia, and the United States. In addition, the company has recently published the 52-week results of Eydenzelt’s global Phase 3 clinical trial in a prestigious international ophthalmology journal, actively releasing long-term clinical data that demonstrate efficacy and safety to the industry, thereby working to enhance physicians’ confidence in prescribing the drug.

With this latest approval, Celltrion has significantly strengthened its market presence by adding five new products to its U.S. portfolio this year alone, including Eydenzelt, the autoimmune disease treatment “Aptosma,” the bone disease treatments “Stovoclo-Osenvelt,” and the allergy treatment “Omriclo.” Furthermore, this approval marks the successful achievement of the company’s goal to establish a lineup of “11 products” in major global markets such as South Korea, Europe, and the United States by the end of this year.

A Celltrion representative stated, “With the approval of Eydenzelt, we are now able to expand our therapeutic presence and strengthen our market influence in the United States, the world’s largest pharmaceutical market. We will do our utmost to swiftly complete the remaining commercialization procedures for the approved products in the U.S. market and ensure that high-quality biopharmaceuticals are supplied to more patients as quickly as possible.”