Bengaluru: Biocon Biologics Limited (BBL), a subsidiary of Biocon Ltd., has announced that MHRA, Medicines and Healthcare products Regulatory Agency in the UK, has granted marketing authorization for YESAFILI, a biosimilar of Aflibercept.
In September, YESAFILI, received marketing authorization 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.
“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
Aflibercept brand sales in UK were USD 790 million (MAT June 2023, IQVIA LC$*). YESAFILI is a registered trademark of a BBL company.
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Biocon Biologics Limited, a subsidiary of Biocon Limited, is a fully integrated global biosimilars organization. Biocon Biologics has eight commercialized products in global markets. The company has a portfolio of biosimilar assets, including insulins, monoclonal antibodies and conjugated recombinant proteins in therapeutic areas such as diabetology, oncology, immunology, and ophthalmology. Biocon Biologics has invested over USD 1 billion to date in R&D and global scale manufacturing and has end-to-end capabilities for producing drug substance, drug product and delivery devices across multiple sites in India and Malaysia.