Biocon's Biosimilar Yesafili™ Data Published in Journals
Biocon Limited announced the publication of pivotal clinical data supporting the effectiveness of Yesafili™ (aflibercept-jbvf), its biosimilar to Eylea® (Aflibercept). The data, from the Phase III INSIGHT program evaluating MYL-1701P, was published in the British Journal of Ophthalmology and Expert Opinion on Biological Therapy. Key findings indicate similar safety, efficacy, and immunogenicity outcomes for patients continuing on MYL-1701P or switching from the reference aflibercept. Subgroup analyses also demonstrated comparable improvements in visual acuity and retinal thickness, supporting clinical equivalence across diverse diabetic macular edema (DME) populations. Yesafili™ received U.S. FDA approval and interchangeable designation in May 2024. This publication is a milestone as Biocon prepares for its U.S. launch.
Key Highlights
- Pivotal clinical data for Yesafili™ (aflibercept biosimilar) published in peer-reviewed journals.
- Studies show comparable safety, efficacy, and immunogenicity to reference aflibercept.
- Data supports clinical equivalence across diverse diabetic macular edema patient subgroups.
- U.S. FDA approved Yesafili™ with interchangeable designation in May 2024.
- Milestone achieved ahead of upcoming U.S. market launch.
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