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Biocon’s Yesafili™ is First Approved Aflibercept Biosimilar in Canada; July 2025 Launch Planned

Jun 27, 2025

On 27 June 2025, Biocon Biologics announced that Yesafili™, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept, 2mg) has been approved by Health Canada in vial and PFS presentations, becoming the first aflibercept biosimilar approved in Canada.  It is indicated for nAMD, visual impairment due to macular oedema secondary to RVO, diabetic macular oedema (DME) and myopic CNV.

The Canadian launch of Yesafili™ is planned for 4 July 2025, as a result of a March 2024 settlement between Biocon and Regeneron/Bayer.  The July 2025 Canadian launch will be the first launch of Yesafili™ worldwide.  Amgen’s Pavblu™ (aflibercept) was launched in the US in October 2024.

Yesafili™ was the first aflibercept biosimilar approved in Europe in September 2023 (where it is not yet launched).  In the US, both Yesafili™ and Samsung Bioepis’ Opuviz®, were the first approved interchangeable aflibercept biosimilars in May 2024.  Biocon and Regeneron settled US BPCIA litigation regarding aflibercept in April 2025, paving the way for a US launch of Yesafili™ in the second half of 2026, or earlier under certain undisclosed circumstances.