Key Takeaways

  • The CHMP recommended EU marketing authorization for Fovlussea across 5 retinal disease indications

  • Fovlussea is a ranibizumab biosimilar with comparable quality, safety, and efficacy to Lucentis.

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization for Fovlussea (ranibizumab), a biosimilar to Lucentis, for the treatment of several retinal diseases.

The recommendation, issued October 15, 2026, covers 5 indications, including wet age-related macular degeneration (AMD), diabetic macular edema (DME), proliferative diabetic retinopathy (PDR), retinal vein occlusion (RVO), and choroidal neovascularization (CNV).

Accord Healthcare is the applicant for Fovlussea, which will be available as a 10 mg/mL solution for intravitreal injection.

Fovlussea has demonstrated comparable quality, safety, and efficacy to its reference product, Lucentis, which received European Union authorization on January 22, 2007.

The positive CHMP opinion represents a regulatory milestone for Fovlussea but does not constitute final marketing authorization. The European Commission will make the final decision on authorization.