Celltrion Receives Health Canada Approval for Eydenzelt

Celltrion, Inc. has announced that Health Canada has approved Eydenzelt, a biosimilar referencing Eylea (aflibercept 2 mg), for all indications currently approved for Eylea. Eydenzelt will be available in both vial and pre‑filled syringe formats.

“This 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,” said Jungyong Shin, Managing Director at Celltrion Healthcare Canada. Shin added that the company plans to strengthen its Canadian presence by leveraging Celltrion’s manufacturing capabilities and R&D expertise to enhance patient access to high‑quality biosimilar treatments.

Evidence Supporting Approval

Health Canada’s decision is based on the totality of evidence, including analytical, nonclinical, and clinical data.

A global, randomized, double‑masked, parallel‑group Phase III clinical trial evaluated the efficacy, safety, pharmacokinetics, and immunogenicity of Eydenzelt compared with Eylea in patients across approved indications.

       • 348 patients with diabetic macular edema (DME) were enrolled in the 52‑week study.

       • The primary endpoint was the change in best corrected visual acuity (BCVA) at week 8 from baseline.

       • Eydenzelt met predefined equivalence criteria, and secondary endpoints, including safety and immunogenicity, were comparable to those observed with Eylea.

Global Regulatory Status

Eydenzelt is Celltrion’s first Health Canada–approved biologic in ophthalmology. In addition to its Canadian approval, the biosimilar received regulatory clearance from the European Commission in February 2025 and from the U.S. Food and Drug Administration in October 2025.

About Eydenzelt

Eydenzelt is a vascular endothelial growth factor (VEGF) inhibitor referencing Eylea (aflibercept). The product is approved in Canada for all Eylea indications, supported by comprehensive data demonstrating therapeutic equivalence.