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Biocon Biologics, the biosimilars subsidiary of India’s Biocon Ltd, has achieved a significant milestone with its flagship biosimilar Yesafili (aflibercept) now publicly funded in Ontario, Canada. This development follows Health Canada’s approval and marks a pivotal step in expanding affordable access to advanced biologics for serious retinal diseases in Canada’s largest province.
Key Highlights From The Yesafili Public Funding Announcement
Yesafili is the first biosimilar to Eylea (aflibercept) injection to be approved by Health Canada, receiving Notice of Compliance on June 26, 2025. The product launch in Canada was scheduled for July 4, 2025.
Public funding approval in Ontario means Yesafili will be reimbursed under provincial drug plans, making it financially accessible to patients suffering from multiple retinal conditions.
Yesafili acts as a vascular endothelial growth factor (VEGF) inhibitor, indicated for neovascular (wet) age-related macular degeneration (AMD), diabetic macular edema (DME), and visual impairment due to macular edema secondary to retinal vein occlusion (RVO).
The approval and funding are backed by extensive analytical, nonclinical, and clinical data, including the Phase 3 INSIGHT study confirming similarity with Eylea in terms of safety, efficacy, and immunogenicity.
Significance Of Public Funding In Ontario
The public funding of Yesafili is a landmark achievement for Biocon Biologics in Canada, signaling not only regulatory trust but also health system endorsement of this biosimilar. As Ontario is Canada’s most populous province, this translates to substantial patient access and improved affordability.
Healthcare providers in Ontario will now have a reimbursed, high-quality biosimilar alternative for retinal diseases that demand costly and ongoing treatment, potentially easing the financial burden for patients and healthcare budgets alike.
Clinical And Commercial Impact Of Yesafili In Canada
Yesafili’s approval and funding open pathways for broader acceptance and uptake by Canadian ophthalmologists. By offering a cost-effective alternative to branded biologics like Eylea, it could accelerate treatment uptake and adherence among patients with chronic retinal diseases.
The launch in Ontario also reinforces Biocon Biologics’ commitment to global biosimilar leadership and aligns with their strategy of launching in regulated markets with strong healthcare infrastructure.
Biocon’s Global Biosimilar Journey
Yesafili is the tenth biosimilar product commercialized by Biocon Biologics worldwide, reflecting the company’s strong focus on science-led innovation and global commercial reach. Canada is the first country to see Yesafili’s market entry, with further launches planned in key markets including the US in the near future.
Leadership Comments Highlight Strategic Progress
Shreehas Tambe, CEO and Managing Director of Biocon Biologics, described the Health Canada approval and Ontario funding as a pride moment underscoring their commitment to expanding access to affordable, high-quality biologics globally.
Ramy Ayad, Head of Canada at Biocon Biologics, emphasized that Ontario’s public funding of Yesafili fulfills a promise to deliver advanced biologic therapies affordably to Canadian patients managing serious retinal conditions.
Looking Ahead: Market Opportunities And Patient Benefits
With ongoing demographic shifts and growing prevalence of age-related and diabetic eye disorders worldwide, the demand for efficacious and affordable retinal therapies is accelerating. Yesafili’s publicly funded status in Ontario places it as a front-runner biosimilar treatment option in Canada.
Healthcare stakeholders will be keenly observing its market uptake, cost savings, and broader impacts on patient health outcomes. Biocon Biologics’ achievement also sets a strong precedent for future biosimilar launches underpinned by rigorous clinical data and strong public health collaborations.
Sources: Biocon Biologics press release, GlobeNewswire, Express Pharma, Ophthalmology Times
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