Biocon Biologics gets MHRA approval for YESAFILI, biosimilar Aflibercept
In September, YESAFILI received marketing authorisation approval from the European Commission (EC) for the European Union (EU)
Biocon Biologics, a subsidiary of Biocon announced that MHRA, Medicines and Healthcare products Regulatory Agency in the UK, has granted marketing authorisation for YESAFILI, a biosimilar of Aflibercept.
In September, YESAFILI received marketing authorisation approval from the European Commission (EC) for the European Union (EU).
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.
Aflibercept brand sales in UK were $790 million (MAT June 2023, IQVIA LC$*).
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