Biocon Biologics Ltd., a subsidiary of Biocon Ltd., has announced a significant milestone in its U.S. expansion with the confirmation of a market entry date for Yesafili™ (aflibercept-jbvf), an interchangeable biosimilar to the ophthalmology drug Eylea®. The company has reached a settlement and license agreement with Regeneron, paving the way for commercial launch in the second half of 2026, or earlier under specific conditions.
The agreement includes the dismissal of all pending U.S. litigations related to the ‘865 patent and clears the legal path for Yesafili’s commercialization. Yesafili is approved by the U.S. FDA as an interchangeable biosimilar, marking Biocon Biologics’ strategic entry into the ophthalmology space.
“This settlement clears the path for Biocon Biologics to be among the first to bring a high-quality aflibercept biosimilar to patients and healthcare providers in the U.S.,” said Shreehas Tambe, CEO and Managing Director, Biocon Biologics Ltd. He noted that the launch underscores the company’s scientific capability and reinforces its goal of improving access to advanced therapies.
Yesafili™ is intended to treat:
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Neovascular (Wet) Age-Related Macular Degeneration (AMD)
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Macular Edema following Retinal Vein Occlusion (RVO)
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Diabetic Macular Edema (DME)
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Diabetic Retinopathy (DR)
The biosimilar has shown no clinically meaningful differences from Eylea® in terms of efficacy, safety, pharmacokinetics, and immunogenicity, as per a Phase 3 clinical trial conducted in patients with diabetic macular edema.
In addition to the U.S., Biocon Biologics has also secured a similar settlement in Canada, with a confirmed launch date no later than July 1, 2025.
Biocon Biologics continues to expand its biosimilar portfolio globally, with nine biosimilars already commercialized and a strong pipeline under development across multiple therapeutic areas including oncology, immunology, diabetology, and ophthalmology.
Disclaimer: The above information is based on the company’s official disclosure and is not investment advice. Please consult your financial advisor before making any investment decisions.
