CHMP recommends Yesafili, an aflibercept biosimilar
Biocon Biologics, a subsidiary of Biocon said that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Yesafili, an aflibercept biosimilar, the company said in an exchange filing. The company in an exchange filing said that Yesafili, an ophthalmology product, is intended for the treatment of neovascular age-related macular degeneration, visual impairment due to macular oedema secondary to renal vein occlusion, visual impairment due to diabetic macular oedema and visual impairment due to myopic choroidal neovascularisation
It is highly similar to the reference product Eylea (aflibercept). Data shows that Yesafili has comparable quality, safety, and efficacy to Eylea. The CHMP's positive opinion will be considered by the European Commission. The European Commission's decision on the approval is expected by the end of September 2023.
Biocon Biologics acquired the biosimilar business of Viatris including rights to aflibercept biosimilar in 2022.
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