Company

Novartis

2 signals

Disease Area

Source

2 of 2 signals

Strategic Signal

EMA21 May 2026CHMP Positive Opinion● 4/10i

EMA: CHMP Positive Opinion: Vislyfa (ranibizumab)

CHMP issued a positive opinion for Vislyfa (ranibizumab, Lupin Europe) for neovascular age-related macular degeneration, visual impairment, and other retinopathies on May 21, 2026. This represents a new marketing authorization application following the biosimilar pathway for Lucentis (Roche/Novartis). Lupin gains entry into the established anti-VEGF ophthalmology market, joining existing biosimilars competing against originator Lucentis and next-generation Eylea (Regeneron/Bayer). The approval adds another biosimilar option in a market where treatment costs remain a significant access barrier across EU healthcare systems.

OtherLupin Roche Novartis Regeneron Bayer

Strategic Signal

EMA13 May 2026EC Decision: Label Extension / New Indication● 4/10i

EMA: EC Decision: Label Extension / New Indication: Lucentis (ranibizumab)

The European Commission approved a label extension for Lucentis (ranibizumab, Novartis) on May 13, 2026, adding visual impairment due to choroidal neovascularization as a new indication. This represents a Type II variation expanding the existing marketing authorization for the anti-VEGF therapy beyond its current indications for wet age-related macular degeneration, diabetic macular edema, and retinal vein occlusion. Novartis gains broader indication coverage in the competitive anti-VEGF ophthalmology market dominated by Eylea (aflibercept) and emerging biosimilars. The approval follows nearly two decades after the original CHMP opinion, reflecting ongoing indication development for the established therapy.

OtherNovartis