YESAFILI, an aflibercept biosimilar, is an ophthalmology product intended for the treatment of neovascular (wet) age-related macular degeneration, visual impairment due to macular edema secondary to renal vein occlusion, visual impairment due to diabetic macular edema, and visual impairment due to myopic choroidal neovascularization.
The CHMP's positive opinion will be considered by the European Commission, and a decision on approval is expected by the end of September 2023. If approved, YESAFILI will be available in the European Union.
Aflibercept had EU brand sales of approximately $1.8B for the 12 months ending 31 December 2022, according to IQVIA.
BBL is a fully integrated, global biosimilars company that is committed to transforming healthcare and transforming lives by enabling affordable access to high-quality biosimilars for millions of patients worldwide.
Biocon is an innovation-led global biopharmaceuticals company committed to enhance affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets as well as Generic Formulations in the US, Europe & key emerging markets. It also has a pipeline of promising novel assets in immunotherapy under development.
Biocon reported 31% rise in consolidated net profit to Rs 313 crore on a 57% increase in revenue from operations to Rs 3,774 crore in Q4 FY23 over Q4 FY22.
Shares of Biocon fell 0.94% to Rs 264 on 21 July 2023.
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