In a significant milestone, Biocon Biologics Ltd, a subsidiary of Biocon Ltd, on Wednesday (September 20) announced the granting of marketing authorisation by the European Commission (EC) for YESAFILI, a biosimilar of aflibercept.
This decision by the EC follows the positive opinion conveyed by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) in July, paving the way for YESAFILI's introduction into the European Union (EU).
YESAFILI is an ophthalmology product designed to address a range of critical eye conditions, including neovascular (wet AMD) age-related macular degeneration, visual impairment stemming from macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), visual impairment associated with diabetic macular oedema (DME), and visual impairment due to myopic choroidal neovascularisation (myopic CNV).
This biosimilar bears a striking resemblance to the reference product, Eylea (aflibercept), and comprehensive data underscores YESAFILI's comparable quality, safety, and efficacy when compared to Eylea.
Notably, the centralised marketing authorisation bestowed by the EC extends across all EU member states and encompasses the European Economic Area (EEA), encompassing countries like Iceland, Liechtenstein, and Norway.
The approval comes as aflibercept achieved EU brand sales of approximately $1.8 billion during the 12 months leading up to December 31, 2022, as reported by IQVIA.
A company spokesperson said, "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."
YESAFILI, bearing the registered trademark of Biocon Biologics Ltd, signifies a big stride in enhancing treatment options and access to vital medications for patients grappling with debilitating eye conditions in the European region.
Shares of Biocon Ltd ended at Rs 273.50, up by Rs 0.45, or 0.16 percent, on the BSE.
