Sandoz Canada Launches First Ophthalmology Biosimilar Enzeevu for Retinal Diseases
核心洞察
Sandoz Canada (搜索) launched Enzeevu (搜索) (aflibercept), its first ophthalmology biosimilar and an alternative to EYLEA, approved for all indications including wet AMD and diabetic macular edema (搜索).
Health Canada authorized Enzeevu (搜索) after thorough biosimilarity assessment, expanding treatment options for vision-threatening retinal diseases that are leading causes of visual impairment in Canada.
The launch aims to improve affordability and access to anti-VEGF therapy for thousands of patients nationwide, supporting sustainable healthcare systems while maintaining clinical effectiveness.
Sandoz Canada (搜索) has launched Enzeevu (搜索) (aflibercept), marking the company's entry into ophthalmology biosimilars and expanding access to affordable treatment options for serious retinal diseases across Canada. The biosimilar received Health Canada's Notice of Compliance and is approved for all indications of the reference medicine EYLEA, including neovascular age-related macular degeneration (搜索) and diabetic macular edema (搜索).
Comprehensive Indication Coverage
Enzeevu (搜索) is authorized for five key retinal conditions that represent leading causes of vision impairment in Canada, particularly affecting older adults and people living with diabetes. The approved indications include neovascular (wet) age-related macular degeneration (AMD), visual impairment due to macular edema secondary to central retinal vein occlusion (搜索) (CRVO), visual impairment due to macular edema secondary to branch retinal vein occlusion (搜索) (BRVO), diabetic macular edema (搜索) (DME), and myopic choroidal neovascularization (搜索) (myopic CNV).
"With the growing prevalence of retinal diseases, access to effective and affordable treatment options has never been more important," said Michel Robidoux, President and General Manager of Sandoz Canada (搜索). "By offering a biosimilar to one of the most widely used therapies in this field, we are helping to improve affordability and access for thousands of patients nationwide."
Regulatory Assessment and Drug Characteristics
Health Canada's approval followed a thorough biosimilarity assessment that included evaluation of physicochemical properties, functional assays, and comparative quality attributes versus the reference product EYLEA. The regulatory decision was affirmed through a comparative analytical and functional assessment using the established "totality of evidence" approach for biosimilars.
Despite minor differences in glycosylation patterns and impurity profiles identified during the assessment, these variances are not expected to meaningfully impact clinical efficacy, pharmacokinetics, or safety according to Health Canada's Summary Basis of Decision.
Enzeevu (搜索) is supplied as a 2 mg/0.05 mL solution for intravitreal injection in a single-use pre-filled syringe, delivering a single dose of 2 mg aflibercept. The product has a similar appearance to the reference medicine, supporting continuity of care and facilitating the transition for patients currently receiving treatment.
Mechanism of Action and Clinical Context
Aflibercept functions as a recombinant fusion protein that acts as a soluble decoy receptor for VEGF-A (搜索), VEGF-B (搜索), and placental growth factor (搜索) (PlGF), blocking ligand binding to VEGF receptors (搜索) on endothelial cells in the retina. This inhibition reduces pathological angiogenesis and vascular permeability, the key pathophysiologic processes underlying neovascular AMD, DME, and retinal vein occlusion-associated macular edema.
The reference product EYLEA has been widely adopted since its initial regulatory approvals based on pivotal Phase 3 trials demonstrating significant improvements in best-corrected visual acuity (BCVA) and macular thickness versus control interventions in wet AMD and DME populations.
Market Context and Healthcare Impact
Age-related macular degeneration and diabetic retinal diseases represent leading causes of visual impairment globally and within Canada, particularly among aging and diabetic populations. Conventional anti-VEGF therapies, including aflibercept, ranibizumab, and bevacizumab, have revolutionized outcomes but impose substantial economic burdens due to high drug costs and repeated intravitreal administrations.
Enzeevu (搜索) joins other aflibercept biosimilars in the Canadian market, including Yesafili, which was the first biosimilar to EYLEA authorized by Health Canada in 2025 and launched with provincial public funding in Ontario. Other manufacturers have also received approvals for aflibercept biosimilars such as Eydenzelt under similar regulatory frameworks.
Patient Support and Safety Considerations
Patients and healthcare professionals will benefit from a comprehensive patient support program during treatment with Enzeevu (搜索), providing practical support and guidance throughout the entire patient experience. The safety profile includes risks inherent to intravitreal injections, such as endophthalmitis and retinal detachment, as well as intraocular inflammation, which clinicians must monitor in practice.
It is important to note that Health Canada does not currently designate biosimilars as automatically substitutable at the pharmacy level, and clinicians should be familiar with provincial policies and institutional protocols governing substitution.
Strategic Portfolio Expansion
This launch reinforces Sandoz's purpose of pioneering access for patients and reflects the company's continued commitment to expanding its biosimilars portfolio into new therapeutic areas, including ophthalmology. As a Canadian leader in off-patent medicines, Sandoz Canada (搜索) has a product portfolio that includes over 700 generics and biosimilars spanning multiple therapeutic areas. In 2025, 59 million Sandoz prescriptions were issued in Canada according to IQVIA Compuscript data.