Biocon Biologics gets EMA Committee positive opinion for Yesafili

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.

Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd, said, “We are very pleased to receive a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for our YESAFILI biosimilar. This is further confirmation of our strong commitment to providing high-quality and affordable medicines and represents another significant milestone as we continue to expand our biosimilar offerings across the globe, building on our robust presence in oncology and diabetes. We look forward to making a meaningful difference to patients in the EU impacted by macular degeneration and diabetic retinopathy through YESAFILI.”

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