“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,” said Jungyong Shin, Managing Director at Celltrion Healthcare Canada. “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.”
The Health Canada approval is based on totality of evidence including analytical, nonclinical, and clinical data. A global, randomized, double-masked, parallel-group, multicenter Phase III study evaluated the efficacy, safety, pharmacokinetics, and immunogenicity of Eydenzelt compared to Eylea in patients with approved indications. The 52-week trial included 348 patients with diabetic macular edema (DME). The primary endpoint was the change in best corrected visual acuity measured at week 8 from baseline, comparing Eydenzelt and Eylea. Results of the study showed that Eydenzelt met the predefined equivalence criteria, and secondary endpoints of efficacy, safety, and immunogenicity also showed trends similar to Eylea.2
Eydenzelt is Celltrion's first Health Canada-approved biologic product in ophthalmology. Eydenzelt was also approved by the European Commission (EC) and the U.S. Food and Drug Administration (FDA) in February and October 2025, respectively.
About Eydenzelt®
Eydenzelt® is a vascular endothelial growth factor (VEGF) inhibitor referencing Eylea® (aflibercept). Eydenzelt is approved based on a comprehensive data confirming the therapeutic equivalence Eylea. In Canada Eydenzelt is approved for the treatment of all indications approved for Eylea.
About Celltrion Inc.
Celltrion is a leading biopharmaceutical company that specialises in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, haematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines.
About Celltrion Healthcare Canada Limited
Celltrion Healthcare Canada is committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with Health Canada regulations. With the approval of Eydenzelt®, Celltrion now has ten products across eight biosimilars approved by Health Canada: Remdantry™/ Remsima® SC (infliximab), Yuflyma® (adalimumab), Vegzelma® (bevacizumab), SteQeyma® (ustekinumab), Omlyclo® (omalizumab), Stoboclo® / Osenvelt® (denosumab), Avtozma™ (tocilizumab) and Eydenzelt® (aflibercept 2mg).
For more information, please visit: https://www.celltrionhealthcare.ca
