YESAFILI, an ophthalmology product, is designed for the treatment of neovascular (wet-AMD) age-related macular degeneration, visual impairment due to macular edema secondary to retinal vein occlusion (branch RVO or central RVO), visual impairment due to diabetic macular edema (DME), and visual impairment due to myopic choroidal neovascularization (myopic CNV). It is highly similar to the reference product Eylea (aflibercept). Data demonstrates that YESAFILI possesses comparable quality, safety, and efficacy to Eylea, according to the company’s statement.
The centralized marketing authorization granted by the EC applies to all EU Member States and European Economic Area (EEA) countries, including Iceland, Liechtenstein, and Norway. IQVIA reported EU brand sales of approximately $1.8 billion for Aflibercept in the 12 months ending December 31, 2022.
A spokesperson from the company stated, “We are very pleased to receive the European Commission’s approval of our YESAFILI biosimilar as we continue to expand our biosimilar offerings across the globe, building on our oncology and diabetes product portfolio. We look forward to making a meaningful difference to patients in the EU impacted by macular degeneration and diabetic retinopathy.”
It is important to note that YESAFILI is a registered trademark of a BBL company.
