The European Commission has approved the ophthalmology biosimilar Yesafili from Biocon Biologics

21 Sep 2023 , 01:33 PM

Yesafili, a biosimilar to Aflibercept, has been given marketing authorization in the European Union (EU) by the European Commission (EC), according to a news release issued by Biocon Biologics on September 20.

After the European Medicines Agency’s favourable assessment and recommendation for Yesafili’s clearance in July, the EC made its decision.

Yesafili, an ophthalmology product, is used to treat neovascular (wet AMD), age-related macular degeneration, visual impairment brought on by diabetic macular oedema (DME), central or branch retinal vein occlusion, and myopic choroidal neovascularization (myopic CNV), as well as visual impairment brought on by macular oedema secondary to retinal vein occlusion. It closely resembles the benchmark product, Eylea (aflibercept). According to data, Yesafili and Eylea are comparable in terms of quality, safety, and effectiveness.

All EU member states as well as Iceland, Liechtenstein, and Norway that are members of the European Economic Area (EEA) are eligible to use the centralised marketing authorization that the EC has issued.

Nearly half of Biocon Limited’s consolidated revenue of Rs 115,501 million, up 38% from the previous fiscal year, came from the biosimilar sector, which had a growth of 61% in FY 23.

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

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