Health Canada Approves Aflivu, Eylea Biosimilar

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

Aflivu Marks Apotex’s First Ophthalmic Biosimilar

According to a press release issued by Apotex, this approval represents the Canadian-based global health company’s first ophthalmic biosimilar and its fourth biosimilar approval since 2016. The growing biosimilar portfolio aligns with Apotex’s strategy to expand its biologics offerings as part of its Journey of Health initiative.

Raymond Shelley, President of Apotex Canada, commented on the significance of this milestone:

“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.”

Clinical Perspectives on the Importance of Biosimilars

Bernard R. Hurley, BSc, MD, FRCSC, Assistant Professor at the University of Ottawa Eye Institute, underscored the value of biosimilars in ophthalmology:

“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.”

Ghassan Cordahi, MD, FACS, Assistant Clinical Professor in the Department of Ophthalmology at Université de Montréal, also highlighted the clinical benefits:

“In clinical practice, having access to a broader range of therapeutic options can empower physicians to tailor care to individual patients' needs. Aflibercept has been a cornerstone in managing retinal diseases, and the introduction of Aflivu offers a more affordable alternative without compromising quality.”