Biocon Biologics Receives MHRA Approval For YESAFILI Biosimilar In The UK
Biocon Biologics (BBL), a subsidiary of Biocon, has received marketing authorisation for YESAFILI, a biosimilar of Aflibercept from the Medicines and Healthcare Products Regulatory Agency (MHRA), in the UK, the company informed in an exchange filing on Monday.
In September, YESAFILI received marketing authorisation approval from the European Commission (EC) for the European Union (EU), the company further informed.
The statement from the company said, 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) and is highly similar to the reference product Eylea (aflibercept).
As per the company's statement, 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. This approval will expand our biosimilar offerings to patients across the globe, building on our oncology and diabetes product portfolios," said Company Spokesperson Aflibercept.
The brand sales in the UK were USD 790 million, the company stated.
