Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd, on Monday announced that the European Medicines Agency’s Commitee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of YESAFILI, an aflibercept biosimilar, the company announced through an exchange filing.
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.
The CHMP positive opinion will be considered by the European Commission. The European Commission decision on the approval is expected by the end of September 2023.
We are very pleased to receive a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for our YESAFILI® biosimilar. This is further confirmation of our strong commitment to providing high-quality and affordable medicines and represents another significant milestone as we continue to expand our biosimilar offerings across the globe, building on our robust presence in oncology and diabetes, said Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd.
Aflibercept had EU brand sales of approximately $1.8B for the 12 months ending December 31, 2022, according to IQVIA.
Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.
Aflibercept is a fusion protein consisting of portions of human VEGF (Vascular Endothelial Growth Factor) receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 and produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology