Celltrion receives Health Canada approval for Eydenzelt®, a biosimilar referencing Eylea® (aflibercept 2mg)

• Eydenzelt^® a biosimilar referencing Eylea^®, receives a Notice of Compliance from Health Canada (aflibercept 2mg)
• 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 expands its biosimilars portfolio into ophthalmology reinforcing commitment to broader patient access in Canada

TORONTO, Ontario--(BUSINESS WIRE)--Celltrion, Inc. today announced that Health Canada has approved Eydenzelt^®, a biosimilar referencing Eylea^® (aflibercept 2mg), in both vial and pre-filled syringe format, for treatment of all indications approved for Eylea.¹

“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.

Notes to Editors:

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.¹

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. For more information, please visit our website www.celltrion.com/en-us and stay updated with our latest news and events on our social media - LinkedIn, Instagram, X, and Facebook.

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

Eydenzelt^® is trademarks of Celltrion, Inc. and are used under license.
Eylea^® is registered trademarks of Bayer Inc.

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¹ Eydenzelt Product Monograph. Celltrion Inc. November 2025. Product information from Health Canada
² Brown M et al. Long-Term Efficacy and Safety of CT-P42 in Patients with Diabetic Macular Edema: 52-Week Results from a Phase 3 Randomized Clinical Trial. Ophthalmol Ther. 2025 Nov;14:2769-2783. doi: 10.1007/s40123-025-01197-w. Epub 2025 Aug 29. Available at: https://link.springer.com/article/10.1007/s40123-025-01197-w [Last accessed Nov 2025]