Aug 5, 2026 · 4 min · 5 segments
An interchangeable biosimilar to Eylea is launched in the US; patient enrollment is completed in two global phase 3 clinical trials evaluating Duravyu for diabetic macular edema; and Topcon receives…
Kendall O'ConnorHost
In our top story, Biocon announced the US commercial launch of Yesufili, an interchangeable biosimilar to EYLEA.
Yesufili is a VEGF inhibitor indicated for the same ophthalmic conditions as reference aflibercept two milligram, including wet AMD, DME, diabetic retinopathy, macular edema following RVO and ROP.
The FDA approved Yesufili in May 2024 and granted the product interchangeable designation, allowing pharmacy-level substitution for the reference product.
The FDA approval of Yesufili was supported by an analytical, non-clinical, and clinical development program demonstrating biosimilarity to reference aflibercept two milligram.
The pivotal Phase III INSIGHT trial evaluated Yesufili in patients with DME, comparing the biosimilar with aflibercept.
According to Biocon, the study demonstrated no clinically meaningful differences between the two products in pharmacokinetics, efficacy, safety, or immunogenicity, supporting the biosimilar's approval and interchangeable designation.
Last year, India-based Biocon announced a settlement and license agreement with Regeneron that cleared the way to commercialize Yesufili in the US in the second half of 2026.
In our top story, Biocon announced the US commercial launch of Yesufili, an interchangeable biosimilar to EYLEA.
Yesufili is a VEGF inhibitor indicated for the same ophthalmic conditions as reference aflibercept two milligram, including wet AMD, DME, diabetic retinopathy, macular edema following RVO and ROP.
The FDA approved Yesufili in May 2024 and granted the product interchangeable designation, allowing pharmacy-level substitution for the reference product.
The FDA approval of Yesufili was supported by an analytical, non-clinical, and clinical development program demonstrating biosimilarity to reference aflibercept two milligram.
The pivotal Phase III INSIGHT trial evaluated Yesufili in patients with DME, comparing the biosimilar with aflibercept.
According to Biocon, the study demonstrated no clinically meaningful differences between the two products in pharmacokinetics, efficacy, safety, or immunogenicity, supporting the biosimilar's approval and interchangeable designation.
Last year, India-based Biocon announced a settlement and license agreement with Regeneron that cleared the way to commercialize Yesufili in the US in the second half of 2026.
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