Celltrion Receives Canadian Approval for Eylea Biosimilar 'Eydenzelt'

Strengthening Presence in North America, the World's Largest Market

Celltrion announced on the 28th that it has received marketing authorization from Health Canada for its biosimilar to the ophthalmic disease treatment Eylea (ingredient: aflibercept), named Eydenzelt (development code: CT-P42).

Celltrion obtained approval in Canada for all indications held by the original drug for adults, including neovascular (wet) age-related macular degeneration (wAMD), macular edema secondary to retinal vein occlusion (RVO), diabetic macular edema (DME), and myopic choroidal neovascularization (myopic CNV). The approved formulations are Eydenzelt Vial and Eydenzelt Prefilled Syringe (PFS).

Aerial view of Celltrion Plant 2 in Songdo, Incheon. Photo by Kim Hyunmin kimhyun81@

Celltrion is accelerating its global market expansion by consecutively acquiring approvals for Eydenzelt in major countries, including South Korea, the European Union (EC), Australia, the United States, and Canada. In particular, with approvals in both the United States and Canada, the company has further strengthened its presence in North America, the world's largest pharmaceutical market. Celltrion plans to swiftly complete the remaining commercialization procedures to drive revenue growth.

The original drug for Eydenzelt, Eylea, is a blockbuster ophthalmic disease treatment that achieved global sales of 9.523 billion dollars (approximately 13.3322 trillion won) last year.

Canada is one of the countries actively promoting biosimilar-friendly policies, and has recently hinted at possible regulatory relaxations and institutional improvements, aligning itself with the global pro-biosimilar trend. Celltrion has already established a diverse product portfolio in Canada covering therapeutic areas such as autoimmune diseases, oncology, allergies, and bone diseases. With this latest approval for an ophthalmic treatment, the company is expected to further expand its therapeutic scope and strengthen its influence in the local market.

A Celltrion representative stated, "We are steadily enhancing our competitiveness in the North American market through continuous portfolio expansion," adding, "With this approval in Canada, Eydenzelt is now authorized in both major North American markets. We will expedite the remaining commercialization procedures to actively drive sales growth."

This content was produced with the assistance of AI translation services.