Biocon Biologics gets positive CHMP opinion for YESAFILI, biosimilar Aflibercept

Biocon Biologics, a subsidiary of Biocon announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of YESAFILI, an aflibercept biosimilar.

YESAFILI, an ophthalmology product, is intended for the treatment of neovascular (wet AMD) age-related macular degeneration, visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), visual impairment due to diabetic macular oedema (DME) and visual impairment due to myopic choroidal neovascularisation (myopic CNV). It is highly similar to the reference product Eylea (aflibercept). Data shows that YESAFILI has comparable quality, safety, and efficacy to Eylea.

The CHMP positive opinion will be considered by the European Commission. The European Commission decision on the approval is expected by the end of September 2023.

Aflibercept had EU brand sales of approximately $1.8 billion for the 12 months ending December 31, 2022, according to IQVIA.

Aflibercept is a fusion protein consisting of portions of human VEGF (Vascular Endothelial Growth Factor) receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 and produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.