Biocon Bags Canadian OK for Yesafili After Patent Face-Off

Biocon Biologics has received Health Canada’s tentative approval for Yesafili, its biosimilar to Eylea (aflibercept), clearing a major regulatory hurdle for entry into the Canadian market. The approval follows a settlement with Bayer and Regeneron, the makers of Eylea, resolving multiple patent disputes in Canada’s Federal Court.

 

Yesafili is used to treat several serious eye conditions, including wet age-related macular degeneration (AMD), diabetic macular edema, and retinal vein occlusion. It’s designed to match the efficacy and safety of Eylea, a blockbuster drug with global sales in the billions.

 

Under the agreement, Biocon Biologics has secured a market entry date no later than July 1, 2025, for Yesafili 2 mg vials and prefilled syringes. While the product is not yet commercially launched, this approval positions Biocon to tap into Canada’s growing demand for affordable biologics.

 

This move is part of Biocon’s broader strategy to expand its biosimilar footprint globally. Yesafili has already received marketing authorization in the UK and the EU, and Canada now joins the list of key markets where Biocon is set to compete.

 

The approval also reflects Health Canada’s confidence in the biosimilar’s quality, safety, and efficacy. With the patent roadblocks cleared and regulatory green light in hand, Biocon is now gearing up for a mid-2025 launch that could reshape competition in the ophthalmology space.

 

Sources: Business Standard, Biocon Biologics, HealthCare Middle East & Africa