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Biocon shares jump 4 per cent after subsidiary secures US market entry for Yesafili

Yesafili is used to treat several different types of ophthalmology conditions. It is a biosimilar of its reference product EYLEA, the company said in a statement.

ENS Economic Bureau

BENGALURU: Biopharmaceutical company Biocon's share price on Tuesday jumped over 4 per cent after its subsidiary Biocon Biologics Ltd (BBL) announced its settlement and licence agreement with Regeneron that clears the way to commercialise Yesafili, an interchangeable biosimilar aflibercept, in the US.

Shares settled at Rs 329.45 apiece, a 4.08 per cent increase from its previous close.

Yesafili is used to treat several different types of ophthalmology conditions. It is a biosimilar of its reference product EYLEA, the company said in a statement.

Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd said this settlement clears the path for Biocon Biologics to be among the first to bring a reliable, high-quality aflibercept biosimilar to patients and healthcare providers in the US.

"As the first to-file interchangeable biosimilar to Eylea, YESAFILI affirms our scientific strength and marks our strategic entry into Ophthalmology, expanding our footprint in the US and advancing our mission to increase access to life-changing treatments," Tambe said.

Biocon Biologics and Regeneron executed the settlement agreement to dismiss the pending appeal at the US Court of Appeals for the Federal Circuit (USCAFC) and the pending litigation at the US District Court for the Northern District of West Virginia, Clarksburg Division.

This agreement enables the Company to launch in the US in the second half of calendar year 2026 or earlier in certain circumstances, BBL added.

Yesafili is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration (AMD) and Diabetic Retinopathy (DR), among others.

Previously, the US Food and Drug Administration (US FDA) approved Yesafili, an interchangeable biosimilar aflibercept in May 2024. Additionally, Biocon Biologics secured a settlement agreement in Canada with Bayer Inc. and Regeneron Pharmaceuticals for the launch of Yesafili no later than July 1, 2025.

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