Health Canada approves aflibercept biosimilar Aflivu

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Health Canada has approved Aflivu (aflibercept), a biosimilar to Eylea, indicated for the treatment of neovascular age-related macular degeneration (AMD), macular edema secondary to central or branch retinal vein occlusion (RVO), treatment of diabetic macular edema (DME), and treatment of myopic choroidal neovascularization.

According to the press release¹ issued by Apotex, this approval marks the Canadian-based global health company’s first ophthalmic biosimilar and its fourth biosimilar since 2016. This expanding inventory of products is in line with the company’s intent to grow its biologics portfolio and execution of its Journey of Health strategy.

Raymond Shelley, President, Apotex Canada spoke to the impact this approval will have on Candian patients, saying, "With Aflivu, we're expanding affordable treatment options for Canadians affected by retinal diseases. Apotex continues to deliver innovative, patient-focused solutions across our growing portfolio of brands, biosimilars, generics and consumer health products."¹

Bernard R. Hurley, BSc, MD, FRCSC, Assistant Professor at the University of Ottawa Eye Institute is also quoted in the news release¹, noting the importance of biosilimars: "The approval of Aflivu represents a positive advancement in ophthalmic care. 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 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."¹

About Apotex

Apotex is a Canadian-based global health company. With a mission to 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, Apotex is the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.¹

Reference:

1. Apotex receives Health Canada approval for Aflivu™, a biosimilar to Eylea®, available in pre-filled syringe and vial formats. Apotex Inc. July 2, 2025. Accessed July 7, 2025. https://www.prnewswire.com/news-releases/apotex-receives-health-canada-approval-for-aflivu-a-biosimilar-to-eylea-available-in-pre-filled-syringe-and-vial-formats-302496912.html