📰 Biocon Biologics Receives Health Canada Approval to Launch Eye Drug Yesafili
Biocon Biologics Ltd., a global biopharmaceutical company and a subsidiary of Biocon Ltd, has received the green light from Health Canada to launch Yesafili, a biosimilar version of aflibercept (reference product: Eylea). The drug is used to treat multiple retinal disorders, including neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME).
The approval marks another milestone for Biocon Biologics in expanding its biosimilar footprint in regulated markets like Canada, further cementing its reputation as a key global player in ophthalmology biologics.
👁️ About Yesafili
Yesafili is a biosimilar to Bayer/Regeneron’s Eylea, a leading drug for treating serious eye disorders. Biosimilars are near-identical versions of original biologic drugs and offer cost-effective treatment options to patients.
Health Canada’s approval is based on a robust comparability exercise that demonstrated Yesafili’s efficacy, safety, and quality matched that of its reference product.
🌎 Global Expansion & Impact
Biocon Biologics’ entry into the Canadian ophthalmology market with Yesafili reflects a growing push by the company to:
Democratize access to high-cost biologics
Offer affordable treatment options in global markets
Expand portfolio beyond diabetes and oncology into ophthalmology
This approval follows similar launches in Europe, adding momentum to Biocon’s strategic global growth plan.
❓ FAQ: Yesafili Approval & Biocon Biologics in Canada
Q1. What is Yesafili used for?
Yesafili is used to treat neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and other retinal diseases.
Q2. What is the reference product for Yesafili?
Yesafili is a biosimilar to aflibercept, sold under the brand name Eylea.
Q3. Who approved Yesafili in Canada?
The drug was approved by Health Canada, the country’s national health regulatory agency.
Q4. Why is this approval important for Biocon Biologics?
It strengthens Biocon’s position in the global biosimilar market, especially in ophthalmology—a growing segment in biologics.
Q5. Will Yesafili be cost-effective compared to Eylea?
Yes. As a biosimilar, Yesafili is expected to be more affordable, improving patient access to critical eye care treatments.
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Reported by Benny on June 27, 2025.
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