EYDENZELT, Celltrion’s biosimilar referencing EYLEA, approved in Canada

Health Canada has approved Celltrion’s Eydenzelt, a biosimilar referencing Eylea (aflibercept 2 mg), in both vial and pre-filled syringe format, for the treatment of all indications approved for Eylea, which in the US include neovascular (wet) age-related macular degeneration (wAMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy (DR)

The Health Canada approval was based on a “totality of evidence including analytical, nonclinical, and clinical data.” Included was a global, randomized, double-masked, parallel-group, multicenter phase 3 study that evaluated the efficacy, safety, pharmacokinetics, and immunogenicity of Eydenzelt compared to Eylea in patients with approved indications.

The phase 3 trial was 52 weeks and included 348 patients with DME. The primary endpoint of the trial was change in best corrected visual acuity (BCVA) measured at week 8 from baseline, comparing Eydenzelt and Eylea. According to the company, the trial showed that Eydenzelt met the predefined equivalence criteria and secondary endpoints of efficacy and safety. Additionally, immunogenicity also showed trends similar to Eylea, according to the trial data.

Additionally, study findings demonstrated both treatment groups had progressive improvement in BCVA from baseline to week 16 and saw stable levels maintained through week 52. The company also noted no significant difference observed between the 2 groups in secondary endpoints, such as average change in central retinal thickness or overall safety outcomes.²

Jungyong Shin, managing director at Celltrion Healthcare Canada, commented on the Health Canada approval in a press release from the company, saying, “Today’s approval lays a solid foundation for Celltrion’s expansion into the Canadian ophthalmology market and represents a significant milestone in diversifying the company’s portfolio. Building on this milestone, Celltrion will further strengthen its presence in Canada by leveraging its advanced manufacturing capabilities and R&D expertise to improve patient access to high-quality biosimilar treatments.”

Furthermore, the company noted that this approval marks Celltrion's first Health Canada-approved biologic product in ophthalmology. Eydenzelt was also approved by the European Commission (EC) in February 2025³ and the US Food and Drug Administration (FDA) in October 2025.⁴ The FDA approval was based on the same trial data as the Health Canada approval.

References:

1. Celltrion receives Health Canada approval for Eydenzelt^®, a biosimilar referencing Eylea^® (aflibercept 2mg). Published November 27, 2025. Accessed December 2, 2025. https://www.businesswire.com/news/home/20251119058907/en/Celltrion-receives-Health-Canada-approval-for-Eydenzelt-a-biosimilar-referencing-Eylea-aflibercept-2mg

2. Filkins K. Celltrion announces phase 3 trial data for EYDENZELT. Published September 7, 2025. Accessed October 10, 2025. https://www.ophthalmologytimes.com/view/celltrion-announces-phase-3-trial-data-for-eydenzelt

3. Hattie H. CHMP of the European Medicines Agency issues positive opinion on 2 aflibercept biosimilars. Published February 3, 2025. Accessed October 10, 2025. https://www.ophthalmologytimes.com/view/chmp-of-the-european-medicines-agency-issues-positive-opinion-on-2-aflibercept-biosimilars

4. Harp MD. EYDENZELT, Celltrion’s biosimilar referencing EYLEA, approved by FDA. Published October 10, 2025. Accessed December 2, 2025. https://www.ophthalmologytimes.com/view/eydenzelt-celltrion-s-biosimilar-referencing-eylea-approved-by-f