Biocon Biologics announced that YESAFILI®, a biosimilar of Aflibercept, has been granted marketing authorization by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.
YESAFILI®, designed for the treatment of neovascular age-related macular degeneration (wet AMD), 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), is categorized as an ophthalmology product. It is highly similar to the reference product Eylea® (aflibercept), with data indicating comparable quality, safety, and efficacy between YESAFILI® and Eylea®.
“We are very pleased to receive the MHRA approval for YESAFILI®, biosimilar Aflibercept, which will enable us to address the needs of patients impacted by macular degeneration and diabetic retinopathy, in the UK. This approval will expand our biosimilar offerings to patients across the globe, building on our oncology and diabetes product portfolios,” said a company spokesperson.