The approval is based on the totality of evidence, including analytical, nonclinical, and clinical data from global Phase III studies demonstrating Eydenzelt is similar in efficacy and safety for all approved indications
Celltrion, Inc. announced that Health Canada has approved Eydenzelt, a biosimilar referencing Eylea, in both vial and pre-filled syringe format, for treatment of all indications approved for Eylea.
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“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.”
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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.
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.
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Source- businesswire
