Biocon Biologics receives marketing authorisation for YESAFILI by MHRA in UK

Bengaluru: Biocon Biologics Limited (BBL) announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, has granted marketing authorisation for YESAFILI, a biosimilar of Aflibercept.

In September, the biosimilar received marketing authorisation approval from the European Commission (EC) for the European Union (EU).

Being an ophthalmology product, it 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.

“We are very pleased to receive the MHRA approval for YESAFILI, biosimilar Aflibercept, which will enable us to address the needs of patients impacted by macular degeneration and diabetic retinopathy, in the UK.” Company Spokesperson said.
Aflibercept brand sales in the UK were $790 million (MAT June 2023, IQVIA local currency sales converted to US dollars at constant exchange rates).