European Medicines Agency recommends approval of aflibercept biosimilar
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Key takeaways:
- Yesafili is intended to treat wet age-related macular degeneration and other retinal conditions.
- The European Commission decision on approval is expected by the end of September.
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended approval of Yesafili, an aflibercept biosimilar, according to a press release from Biocon Biologics.
Yesafili is intended to treat wet age-related macular degeneration and visual impairment due to macular edema secondary to retinal vein occlusion, diabetic macular edema or myopic choroidal neovascularization.
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Data show that Yesafili has comparable quality, safety and efficacy to the reference product Eylea (aflibercept, Regeneron), the release said.
“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,” Shreehas Tambe, CEO and managing director of Biocon Biologics, said in the release. “We look forward to making a meaningful difference to patients in the EU impacted by macular degeneration and diabetic retinopathy through Yesafili.”
Biocon expects a decision on approval from the European Commission by the end of September.
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