Company

Roche

2 signals

Next earnings: 23 July 2026

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

EMA14 Apr 2026EC Decision — New Marketing Authorisation● 6/10i

EMA: EC Decision — New Marketing Authorisation — Pavblu (aflibercept)

The European Commission approved aflibercept (Pavblu, Amgen) for neovascular age-related macular degeneration, visual impairment from retinal vein occlusion, diabetic macular edema, and myopic choroidal neovascularization on April 14, 2026. This represents a new marketing authorization following CHMP positive opinion in January 2025. The approval establishes Amgen's entry into the competitive anti-VEGF ophthalmology market, challenging established players Regeneron/Bayer (Eylea) and Roche (Lucentis/Vabysmo) across multiple retinal indications.

OtherAmgen Regeneron Bayer Roche