The US Food and Drug Administration (FDA) has approved Yesafili (aflibercept-jbvf) and Opuviz (aflibercept-yszy), two interchangeable biosimilars to the reference product Eylea (aflibercept), for the treatment of macular degeneration and other eye conditions.
Yesafili is a trademark of Biosimilars Newco, a Biocon Biologics company. Opuviz is a trademark of Biogen and is manufactured by Samsung Bioepis.
Both Yesafili and Opuviz function by hindering vascular endothelial growth factor (VEGF) to prevent abnormal blood vessel growth within the eye.
The products aim to mitigate retinal damage and help maintain vision.
The approved indications for these biosimilars include neovascular (wet) age-related macular degeneration, diabetic macular oedema, macular oedema following retinal vein occlusion, and diabetic retinopathy.
Administered intravitreally into the eye as a 2mg injectable solution, Yesafili and Opuviz follow specific dosing regimens.
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The FDA’s decision is underpinned by a thorough review of scientific evidence confirming that both biosimilars are highly similar to Eylea and that no clinically meaningful differences in their safety and efficacy are observed.
The analytical comparisons involved multiple lots of Yesafili or Opuviz against several lots of Eylea, examining a wide spectrum of product quality attributes.
Clinical findings from comparative studies in patients further supported the approval, demonstrating equivalent outcomes in efficacy, safety and immunogenicity when compared to Eylea.
Biocon Biologics CEO and managing director Shreehas Tambe stated: “The FDA approval of Yesafili (aflibercept) as the first interchangeable biological product to Eylea is a significant milestone for Biocon Biologics marking our entry into ophthalmology, a new therapeutic area in the United States.
“This approval builds on our successful track record of bringing the first interchangeable insulin, SEMGLEE, the first biosimilar Trastuzumab, OGIVRI, and the first biosimilar Pegfilgrastim, FULPHILA, to patients in the United States.”
