Biocon biologics receives marketing approval by MHRA for YESAFILI in UK

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

 

This approval follows the green light granted by the European Commission (EC) for marketing authorisation in the European Union (EU) back in September.

YESAFILI, classified as an ophthalmology product, is designed to address various eye conditions, including 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). The biosimilar exhibits a high degree of similarity to the reference product Eylea® (aflibercept).

Commenting on this, a company spokesperson stated, “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.”

In the UK, Aflibercept brand sales reached USD 790 million as of June 2023, according to IQVIA LC$.

Biocon Biologics is a global biopharmaceutical company that develops and manufactures high-quality, affordable biosimilars and insulins. The company is headquartered in Bengaluru, India, and has a global presence with operations in over 120 countries.