Celltrion Receives Canadian Approval for Eylea Biosimilar ‘Eydenzelt’

Approved in Korea, Europe, and the U.S., Celltrion now adds Canada
Its portfolio expands across autoimmune, bone, and eye diseases
"With North America gaining momentum, commercialization will accelerate"

Celltrion CI (Source: Celltrion)

[Kim Saemi, Edaily Repoter] Celltrion announced on the 28th that it has received marketing authorization from Health Canada for Eydenzelt (EYDENZELT, development name CT-P42), its biosimilar to the ophthalmic treatment Eylea (aflibercept).

In Canada, Celltrion has obtained approval for the same adult indications held by the originator product, including neovascular (wet) age-related macular degeneration (wAMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and myopic choroidal neovascularization (myopic CNV).

Approved formulations include Eydenzelt Injection (vial) and Eydenzelt Prefilled Syringe (PFS).

Celltrion is accelerating its global market expansion as it continues to secure approvals for Eydenzelt in major markets including Korea, the European Commission (EC), Australia, the United States, and now Canada. In particular, with approvals in both the U.S. and Canada, the company has further strengthened its position in North America, the world’s largest pharmaceutical market. Celltrion plans to quickly complete the remaining commercialization steps and translate this into sales growth.

The reference product Eylea recorded USD 9.523 billion (KRW 13.3322 trillion) in global sales last year, making it a blockbuster ophthalmology therapy.

Canada is one of the countries actively promoting biosimilar-friendly policies and has recently signaled potential regulatory improvements, such as easing approval requirements, in line with global trends toward biosimilar adoption. Celltrion already has an established portfolio in Canada spanning autoimmune diseases, oncology, allergies, and bone disorders. With this new approval in ophthalmology, the company is expected to further expand its therapeutic coverage and strengthen its market influence.

A Celltrion official stated, “We have been steadily enhancing our competitiveness in the North American market through continuous portfolio expansion,” adding, “With this approval in Canada, we now have authorization for Eydenzelt in both major North American markets, and we plan to swiftly complete the remaining commercialization process to actively drive revenue growth.”

김새미 (bird@edaily.co.kr)