Biocon Biologics’ Yesafili Secures Public Funding in Ontario for Retinal Diseases

Biocon Biologics, a subsidiary of Biocon, announced that its aflibercept biosimilar Yesafili is now publicly funded in Ontario, Canada, for treating a range of retinal diseases. The move is expected to increase patient access to treatment while easing financial strain on the healthcare system.

Scope of Funding

Ontario’s public funding covers both vial and prefilled syringe presentations of Yesafili in the 2 mg/0.05 ml dosage form. With this, patients under the province’s public insurance programme can access treatment at reduced cost, addressing one of the major barriers to biologic therapies.

First Aflibercept Biosimilar in Canada

Yesafili is the first aflibercept biosimilar approved by Health Canada. It is indicated for neovascular (wet) age-related macular degeneration (AMD), diabetic macular oedema (DME), visual impairment due to macular oedema secondary to central and branch retinal vein occlusion (CRVO/BRVO), and myopic choroidal neovascularisation (myopic CNV). These conditions are among the leading causes of irreversible vision loss and affect more than two million Canadians.

Clinical Evidence Supporting Approval

The approval of Yesafili is backed by comprehensive analytical, nonclinical, and clinical data. Notably, the phase 3 INSIGHT study showed that Yesafili demonstrated no clinically meaningful differences from its reference product, Eylea, in terms of efficacy, safety, pharmacokinetics, or immunogenicity in patients with diabetic macular oedema. This strong evidence base reassures both healthcare providers and patients of its reliability.

Company’s Statement

Commenting on the development, Ramy Ayad, Head of Canada at Biocon Biologics in a press release, said, “Ontario's public funding of Yesafili, Canada’s first Eylea biosimilar and our seventh biosimilar in the country, underscores our commitment to expanding access to biologics and building a sustainable biosimilars environment.” He further noted that Yesafili offers “a high-quality, affordable option, removing significant cost barriers for patients and delivering substantial savings to the healthcare system.”

Read More: Biocon Biologics Gains USFDA Approval for Denosumab

Conclusion

Ontario’s decision to fund Yesafili marks a key step in widening access to affordable biologic treatments for retinal diseases. By lowering treatment costs and maintaining clinical equivalence with Eylea, the biosimilar strengthens Biocon Biologics’ presence in Canada’s healthcare market while contributing to long-term system savings.

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