The FDA approved Biocon Biologics Ltd’s first-to-file application for Yesafili (aflibercept-jbvf), an interchangeable biosimilar aflibercept. Yesafili, a vascular endothelial growth factor inhibitor used to treat several different types of ophthalmology conditions, is a biosimilar of its reference product Eylea (aflibercept, Regeneron), the company stated in a press release. 

Yesafili is intended for the treatment of neovascular (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 neovascularisation.

The approval for Yesafili was based on a comprehensive package of analytical, nonclinical and clinical data, the company said. In the Phase 3 INSIGHT study, Yesafili was compared with Eylea in patients with DME. The study demonstrated no clinically meaningful differences between Yesafili and Eylea in terms of pharmacokinetics, safety, efficacy and immunogenicity.  

The approval of Yesafili marks Biocon Biologics' expansion into the ophthalmology therapeutic area in the United States.