The Priority Review

Approvals Brief

CHMP adopts positive opinion on Fovlussea

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on 15 October 2026, recommending a marketing authorisation for Fovlussea, a ranibizumab biosimilar for several retinal conditions. The applicant is Accord Healthcare S.L.U., and the product will be available as a 10 mg/ml solution for injection.

Primary source

EMA medicine page (CHMP opinion), October 16, 2026

Fovlussea (ranibizumab, Ophthalmologicals): EMA CHMP opinion

Read the source: Fovlussea (ranibizumab, Ophthalmologicals): EMA CHMP opinion ema.europa.eu

Machine-summarized from the source above; not independently reported. How we use automation