The EC decision follows the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) positive opinion recommending approval of YESAFILI in July.

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 centralized marketing authorization granted by the EC is valid in all EU Member States as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway.

Aflibercept had EU brand sales of approximately $1.8 billion for the 12 months ending December 31, 2022, according to IQVIA.

Biocon's spokesperson stated: “We are very pleased to receive the European Commission's approval of our YESAFILI® biosimilar as we continue to expand our biosimilar offerings across the globe, building on our oncology and diabetes product portfolio. We look forward to making a meaningful difference to patients in the EU impacted by macular degeneration and diabetic retinopathy.”

Biocon is an innovation led global biopharmaceuticals company, engaged in the production of 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.

The company reported 30% decline in consolidated net profit to Rs 101 crore in Q1 FY24 from Rs 144 crore in Q1 FY23. Consolidated revenues for Q1 FY24 grew 59% YoY to Rs 3,516 crore.

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