The Biocon Biologics, Ltd product moves on to review by the European Commission, with an expected decision in late September 2023.
On Monday, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending approval of YESAFILI®, an aflibercept biosimilar. The opinion was announced in a news release from Biocon Biologics Ltd (BBL,) a subsidiary of Biocon Ltd.1 The European Commission will consider the CHMP opinion and is expected to announce its decision by the end of September.
YESAFILI® is described as “highly similar” to the reference product Eylea® (aflibercept). According to Biocon Biologics, date demonstrates “that YESAFILI® has comparable quality, safety and efficacy to Eylea®.”1 The biosimilar is intended for the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), neovascular (wet AMD) age-related macular degeneration, visual impairment due to myopic choroidal neovascularisation (myopic CNV) and visual impairment due to diabetic macular oedema (DME).
If the European Commission grants marketing authorisation, the company will publish a summary of product characteristics (SmPC) in the European public assessment report (EPAR). That document will contain more detailed recommendations and use cases.1
"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,” said Shreehas Tambe, CEO and managing director of Biocon Biologics. “We look forward to making a meaningful difference to patients in the EU impacted by macular degeneration and diabetic retinopathy through YESAFILI®."1