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

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

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

Amgen Technology (Ireland) UC

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.

Strategic Signal

Amgen's EU approval creates a third major anti-VEGF competitor in ophthalmology, potentially pressuring Regeneron's Eylea franchise which dominates wet AMD and diabetic macular edema markets. European ophthalmologists now have increased leverage in pricing negotiations, particularly in Germany where G-BA assessments favor therapeutic alternatives. This follows the typical EU ophthalmology adoption pattern where biosimilars and new entrants gain traction through hospital tender processes before expanding to outpatient settings.

OtherAmgen Regeneron Bayer Roche

Original Abstract

EMA action: EC Decision — New Marketing Authorisation | Medicine: Pavblu | INN (active substance): aflibercept | Decision date: April 14, 2026 | CHMP opinion: January 30, 2025 | EC decision: April 14, 2026 | Sponsor: Amgen Technology (Ireland) UC | EMA product number: EMEA/H/C/006339 | Revision: 2 | Indication: Pavblu is indicated for adults for the treatment of neovascular (wet) age-related macular degeneration (AMD) (see section 5.1), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) (see section 5.1), visual impairment due to diabetic macular oedema (DME) (see section 5.1), visual impairment due to myopic choroidal neovascularisatio | Geography: European Union (EMA / EC)

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