Biocon Sets 2026 U.S. Launch for Yesafili

Biocon Biologics has announced a settlement and license agreement with Regeneron, enabling the future U.S. launch of Yesafili (aflibercept-jbvf), an interchangeable biosimilar to the reference product Eylea (aflibercept).

Settlement Clears Legal Path for Commercialization

The agreement between Biocon Biologics and Regeneron includes the dismissal of ongoing litigation concerning patent US11084865 (‘865 patent) at the U.S. District Court for the Northern District of West Virginia and an associated appeal at the U.S. Court of Appeals for the Federal Circuit (USCAFC).

This settlement paves the way for U.S. market entry of Yesafili in the second half of 2026, or potentially earlier under certain conditions. The specific terms of the agreement remain confidential.

FDA Approval and Product Overview

Yesafili (aflibercept-jbvf), a vascular endothelial growth factor (VEGF) inhibitor, received FDA approval in May 2024 as an interchangeable biosimilar to Eylea. Interchangeable biosimilars must meet stringent FDA criteria demonstrating they are highly similar to a reference product, with no clinically meaningful differences.

Indications for Use

Yesafili is indicated for the treatment of several retinal and choroidal vascular conditions, including:

• Wet age-related macular degeneration (AMD)

• Visual impairment due to macular edema secondary to retinal vein occlusion (branch or central RVO)

• Diabetic macular edema (DME)

• Myopic choroidal neovascularisation (myopic CNV)

Strategic Significance and Executive Commentary

“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 United States," said Shreehas Tambe, CEO & Managing Director of Biocon Biologics.

“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 U.S. and advancing our mission to increase access to life-changing treatments.”

Global Expansion: Canadian Settlement

In addition to its U.S. strategy, Biocon Biologics has reached a separate settlement agreement in Canada with Bayer and Regeneron Pharmaceuticals, which allows for the commercial launch of Yesafili in Canada by July 1, 2025.