Apotex receives Health Canada approval for Aflivu™, a biosimilar to Eylea®, available in pre-filled syringe and vial formats
Jul 2, 2025Toronto, ON – July 2, 2025, Apotex Inc. ("Apotex" or the “Company”), the Canadian-based global health company, today announced that Health Canada has approved Aflivu™ (aflibercept), a biosimilar to Eylea®, indicated for the treatment of neovascular (wet) age-related macular degeneration, macular edema secondary to central or branch retinal vein occlusion, treatment of diabetic macular edema, and treatment of myopic choroidal neovascularization.
This approval marks a key milestone for Apotex, introducing its first ophthalmic biosimilar and its fourth biosimilar since 2016, and reflecting the Company's commitment to expand its biologics portfolio and execution of its Journey of Health strategy.
“With Aflivu, we’re expanding affordable treatment options for Canadians affected by retinal diseases,” said Raymond Shelley, President, Apotex Canada. “Apotex continues to deliver innovative, patient-focused solutions across our growing portfolio of brands, biosimilars, generics and consumer health products.”
“The approval of Aflivu represents a positive advancement in ophthalmic care,” said Dr. Bernard R. Hurley, BSc, MD, FRCSC, Assistant Professor at the University of Ottawa Eye Institute. “Biosimilars, supported by clinicians, regulators, and manufacturers, have the potential to transform the treatment landscape for retinal diseases, preserving vision and providing quality, cost-effective care for countless Canadians.”
“In clinical practice, having access to a broader range of therapeutic options can empower physicians to tailor care to individual patients’ needs,” said Dr. Ghassan Cordahi, MD, FACS, Assistant Clinical Professor, Faculty of Medicine, Department of Ophthalmology, Université de Montréal. “Aflibercept has been a cornerstone in managing retinal diseases, and the introduction of Aflivu offers a more affordable alternative without compromising quality.”
Aflivu joins Apotex’s successful biosimilar portfolio, which includes Grastofil® (filgrastim), Lapelga® (pegfilgrastim), and Bambevi® (bevacizumab).
About Apotex
Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people around the world, with a broad portfolio of generic, biosimilar, and innovative branded pharmaceuticals, and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico, and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.
Learn more about us at www.apotex.com
Media Contact: [email protected]
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