Celltrion Receives Health Canada Approval for Eydenzelt®, a Biosimilar Referencing Eylea®
Celltrion, Inc. has announced a major regulatory milestone with the approval of Eydenzelt® by Health Canada. The newly approved biosimilar references Eylea® (aflibercept 2mg) and will be available to patients in both vial and pre-filled syringe presentations. With this authorization, Eydenzelt is now approved for all therapeutic indications for which Eylea currently holds approval in Canada, positioning it as an important new treatment option within the ophthalmology and retina care market.
The approval of Eydenzelt marks a significant strategic achievement for Celltrion as it expands its presence in the ophthalmology space and continues to grow a diversified global biosimilar portfolio. With biosimilars increasingly recognized as clinically effective and economically impactful alternatives to high-cost biologics, Eydenzelt has the potential to support wider patient access to vision-preserving treatments that are critical for chronic eye conditions.
Jungyong Shin, Managing Director at Celltrion Healthcare Canada, emphasized the importance of the approval, stating, “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.”
Regulatory Approval Supported by Robust Evidence Package
Health Canada’s authorization of Eydenzelt was based on comprehensive data demonstrating biosimilarity to the reference biologic Eylea. Regulatory review incorporated the totality-of-evidence methodology, including analytical, nonclinical, and clinical assessment.
A key component supporting approval was a global, randomized, double-masked, parallel-group Phase III clinical trial. This multicenter study, designed to assess comparative efficacy and safety, enrolled 348 adult patients diagnosed with diabetic macular edema (DME), one of the most common and visually debilitating retinal diseases treated with aflibercept-based therapy.
The 52-week trial evaluated multiple endpoints, with the primary endpoint measuring change from baseline in best corrected visual acuity (BCVA) at Week 8. This metric is the standard clinical benchmark in evaluating visual function improvement among patients receiving retinal anti-VEGF treatments.
Results from the study demonstrated that Eydenzelt successfully met predefined statistical equivalence criteria for the primary endpoint when compared with Eylea. Additionally, secondary endpoints—including anatomical outcomes, adverse event profiles, pharmacokinetic characteristics, and immunogenicity—also showed comparable trends between both treatment groups. The findings support that Eydenzelt performs similarly to Eylea in terms of efficacy and safety, reinforcing its suitability as an interchangeable therapeutic option.
A New Pathway for Access and Affordability in Ophthalmology
The Canadian ophthalmology market has experienced increasing demand for anti-VEGF biologics, driven by an aging population and rising prevalence of retinal diseases such as diabetic macular edema, neovascular age-related macular degeneration, and retinal vein occlusion. These conditions require continuous and often long-term treatment to prevent irreversible vision loss, creating a substantial clinical and financial burden on patients and healthcare systems.
As new biosimilar options like Eydenzelt enter the Canadian market, ophthalmologists and patients may benefit from expanded treatment choice and potential cost reductions. Introducing biosimilars to high-cost biologic treatment categories has shown, in other therapeutic areas, to stimulate market competition and reduce pricing barriers. This may support broader and earlier adoption of therapy among eligible patients—particularly those requiring ongoing treatment over extended periods.
For Celltrion, this approval reinforces its commitment to advancing biosimilar access and contributing to more sustainable healthcare spending within Canada. The company has expressed plans to expand commercialization efforts and engage with healthcare professionals, particularly retina specialists, to support understanding and adoption of biosimilars in ophthalmology.
Growing Global Regulatory Momentum for Eydenzelt
Eydenzelt represents not only Celltrion’s first ophthalmology biosimilar approval in Canada but also its growing international regulatory success. Earlier in 2025, the European Commission granted marketing authorization, followed by U.S. Food and Drug Administration (FDA) approval in October 2025. These milestone approvals position Eydenzelt as a globally available alternative within one of the most competitive biologics markets worldwide.
The alignment of approvals across major regulatory agencies reflects confidence in the clinical science and manufacturing quality behind Celltrion’s biosimilar development programs. It also supports international harmonization, enabling consistent access to ophthalmology biosimilar options in key regions.
As Celltrion progresses commercialization efforts, the company is expected to continue advancing data generation, post-marketing research, and education initiatives to support physicians, healthcare systems, and patients transitioning toward biosimilar treatment models.
With the Health Canada approval of Eydenzelt, Celltrion takes a meaningful step forward in expanding its biosimilar presence in North America, particularly within therapeutic areas requiring high-value specialty biologics. As biosimilars become increasingly integrated into long-term care pathways, especially in chronic disease treatment models, products like Eydenzelt may play an essential role in improving accessibility, reducing treatment costs, and ensuring continuity of care.
The approval underscores both scientific validation and growing confidence in biosimilar ophthalmic therapies. As the product enters the Canadian market, healthcare stakeholders will be watching closely to understand its impact on treatment adoption trends, patient outcomes, and healthcare affordability.
Eydenzelt now joins Celltrion’s expanding global biosimilar portfolio, marking a pivotal milestone for the company and signaling continued momentum for biosimilar innovation in ophthalmology.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
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.
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
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