Biocon Biologics Secures UK MHRA Marketing Approval For Yesafili

India Pharma Outlook Team | Wednesday, 15 November 2023

 India Pharma Outlook Team
Yesafili, a biosimilar of aflibercept, has been given marketing permission by the UK Medicines and Healthcare products Regulatory Agency (UK MHRA), according to Biocon Biologics, a subsidiary of Biocon.In September, Yesafili, received marketing authorization approval from the European Commission (EC) for the European Union (EU), as per pharmabiz.Yesafili is an ophthalmology product used to treat neovascular (wet AMD) age-related macular degeneration, visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), diabetic macular oedema (DME), and myopic choroidal neovascularisation (myopic CNV). It closely resembles the reference product Eylea (aflibercept). According to the data, Yesafili is of equivalent quality, safety, and efficacy as 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," company spokesperson said.IQVIA LC$ = Local currency sales translated to US dollars at constant exchange rates. Aflibercept brand sales in the UK were US$ 790 million MAT June 2023. Yesafili is a Biocon Biologics registered brand.Biocon Limited is a Bangalore-based Indian biopharmaceutical business Kiran Mazumdar-Shaw created it in 1978. The firm produces generic active medicinal ingredients which are distributed in over 120 countries worldwide, including the United States and Europe.

© 2024 India Pharma Outlook. All Rights Reserved.