 "Biocon Biologics, Biocon logo")
Biocon Biologics said on Tuesday the US Food and Drug Administration (US FDA) has approved the Indian group’s first-to-file application for Yesafili, an interchangeable biosimilar of aflibercept.
Yesafili treats various eye disorders, including neovascular (wet) age-related macular degeneration (AMD), visual impairment due to macular edema secondary to retinal vein occlusion, diabetic macular edema, and myopic choroidal neovascularization. The medication is similar to the reference product Eylea (aflibercept). Studies demonstrate that Yesafili matches Eylea in quality, safety, and efficacy.
"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,” said Shreehas Tambe, chief executive officer and managing director, Biocon Biologics.
“Yesafili is approved for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy,” said Tambe.
Biocon Biologics said the nod for Yesafili marks the company’s entry into the ophthalmology market in the United States, following successful approvals in Europe (September 2023) and the United Kingdom (November 2023), where it became the first biosimilar aflibercept approved. The company has also secured a launch date in Canada for July 1, 2025, as part of a settlement agreement.
In the US, 19.8 million people live with AMD. In 2023, sales of aflibercept, a common treatment for AMD, reached approximately $5.89 billion.
