Apotex Gains Health Canada Approval for Aflivu™, a Significant Step in Retinal Disease Treatment

Apotex Gets Green Light for Aflivu™: A New Era in Retina Care



In a notable advancement for ophthalmic care, Apotex Inc., a Canadian global health company, has garnered approval from Health Canada for Aflivu™ (aflibercept). This biosimilar mirrors the established Eylea® and is poised to address a variety of retinal ailments, including neovascular (wet) age-related macular degeneration, macular edema triggered by central or branch retinal vein occlusion, diabetic macular edema, and myopic choroidal neovascularization. The company announced this pivotal update on July 2, 2025, in Toronto.

Aflivu™ stands as Apotex’s first foray into ophthalmic biosimilars and marks the fourth biosimilar introduction since 2016, underscoring a strong commitment to expanding their biologics offerings as part of their Journey of Health Strategy. As articulated by Raymond Shelley, President of Apotex Canada, “With Aflivu, we’re expanding affordable treatment options for Canadians affected by retinal diseases.” This sentiment resonates deeply in a market increasingly in search of affordable yet effective health solutions.

Dr. Bernard R. Hurley, an Assistant Professor at the University of Ottawa Eye Institute, emphasized the significance of biosimilars like Aflivu in transforming ophthalmic care. He noted, “The approval of Aflivu represents a positive advancement in ophthalmic care. Biosimilars, underpinned by the support of clinicians, regulators, and manufacturers, have the capacity to revolutionize treatment landscapes for retinal diseases. They promise not only to preserve vision but also to deliver quality, cost-efficient care to a multitude of Canadians.”

The clinical community is equally optimistic about Aflivu’s entry into the market. Dr. Ghassan Cordahi, an Assistant Clinical Professor at the Université de Montréal, highlighted that the availability of a broader array of treatment options can enable physicians to customize care tailored to individual patient needs. He remarked, “Aflibercept has been a cornerstone in managing retinal diseases, and the introduction of Aflivu offers a more affordable alternative without compromising quality.”

Joining a well-established biosimilar lineup, Aflivu will join Apotex’s existing products including Grastofil® (filgrastim), Lapelga® (pegfilgrastim), and Bambevi® (bevacizumab). This builds a robust portfolio that aims to improve access to quality healthcare for various ailments. Apotex’s strategic expansion into biosimilars aligns with their overarching mission to deliver affordable healthcare solutions that meet the evolving needs of patients.

As a leader in pharmaceutical innovation, Apotex is committed to enhancing accessibility to groundbreaking medicines and health products globally. With a headquarters in Toronto and a strong presence in regions like the United States, Mexico, and India, Apotex is not only Canada’s largest pharmaceutical company but also a trusted health partner across the Americas for pharmaceutical licensing and product sourcing.

As Aflivu™ sets to make its mark, the healthcare landscape in Canada is poised for transformation. The move stands to enhance patient outcomes through effective treatment solutions while facilitating cost-effective care. This latest development underscores Apotex’s ongoing commitment to innovation and patient-focused care, continuing to make significant strides in the healthcare sector.

For those interested in learning more about Apotex and its expanding product offerings, further information can be found at www.apotex.com.

Topics Health)

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