Biocon Biologics gains EU approval for Aflibercept biosimilar, YESAFILI

Biocon Biologics, a subsidiary of Biocon, announced on Wednesday that it has received marketing authorisation from the European Commission for YESAFILI, a biosimilar of Aflibercept, in the European Union. This approval is in line with the positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency in July.

Designed for ophthalmological use, YESAFILI targets various eye conditions, including neovascular age-related macular degeneration (AMD) and visual impairments resulting from myopic choroidal neovascularisation (CNV). AMD is characterised by blurred central vision due to age-related damage to the macula, while myopic CNV involves the development of abnormal blood vessels beneath the retina, potentially causing fluid and blood leakage.

Demonstrating quality, safety, and efficacy comparable to its reference product, Eylea, YESAFILI is authorised for marketing across all EU member states and the European Economic Area (EEA) countries, including Iceland, Liechtenstein, and Norway.

A company spokesperson said, “Receiving the European Commission’s approval for our YESAFILI biosimilar aligns with our strategy to expand our global biosimilar offerings, building upon our existing oncology and diabetes portfolio.”

According to market research firm IQVIA, Aflibercept generated about $1.8 billion in annual sales in the EU in 2022.