Biocon to Launch Interchangeable Biosimilar Yesafili™ in U.S. by 2026

Biocon Biologics Ltd (BBL), a global biosimilars company and subsidiary of Biocon Ltd, has entered into a settlement and license agreement with Regeneron that facilitates the U.S. commercialisation of Yesafili™ (aflibercept-jbvf), an interchangeable biosimilar of Eylea® (aflibercept).  

As part of this agreement, both parties will dismiss pending legal proceedings in the U.S., including an appeal before the United States Court of Appeals for the Federal Circuit and litigation in the U.S. District Court for the Northern District of West Virginia.  

The settlement enables Biocon Biologics to launch Yesafili in the U.S. by the second half of 2026, or earlier under specific conditions. The detailed terms of the settlement remain confidential. 

FDA Approval and Canadian Settlement Already in Place 

Yesafili received approval from the U.S. Food and Drug Administration (FDA) in May 2024 as an interchangeable biosimilar, granting it the potential to be substituted for its reference product, Eylea®, without the need for physician intervention.  

Additionally, Biocon Biologics had earlier reached a settlement agreement with Bayer Inc. and Regeneron Pharmaceuticals, Inc. in Canada, allowing for the launch of Yesafili in the Canadian market no later than July 1, 2025. 

Therapeutic Use and Efficacy 

Yesafili is used in the treatment of several ophthalmic conditions, including neovascular (wet) age-related macular degeneration (AMD), macular oedema due to retinal vein occlusion (RVO), diabetic macular oedema (DME), and myopic choroidal neovascularisation (myopic CNV).  

As a vascular endothelial growth factor (VEGF) inhibitor, it helps prevent abnormal blood vessel growth in the retina. Studies have demonstrated that Yesafili is highly similar in quality, safety, and efficacy to its reference product, Eylea. 

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Interchangeability Advantage 

Yesafili holds interchangeable status in the U.S., a designation granted to biosimilars that meet additional requirements for substitution. It assures prescribers and patients that Yesafili can deliver the same clinical results as Eylea and can be safely alternated without increased risk. 

Commenting on this, the CEO & Managing Director of Biocon Biologics Ltd, Shreehas Tambe, 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 United States. 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.” 

Conclusion 

With strategic settlements in the U.S. and Canada, and regulatory approvals in place, Biocon Biologics is well-positioned to strengthen its presence in the global ophthalmology biosimilars market through the commercialization of Yesafili. 

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