Skojoy

Application withdrawnHuman

Biosimilar

Details

EMA number	EMEA/H/C/006551
ATC code	S01LA05
Authorisation	-
Revision	-

EMA page

Therapeutic indication

Treatment of age-related macular degeneration (AMD) and visual impairment.

MeSH: Wet Macular Degeneration;Macular Edema;Retinal Vein Occlusion;Choroidal Neovascularization

Group: Ophthalmologicals

Active substances

aflibercept

Marketing Authorisation Holder

Amgen Technology (Ireland) UC

MAH

🇺🇸 Also approved in the US (FDA)

PAVBLU — AMGEN INC, approved 2026-04-28 (BLA761298).

Most reported adverse events (US / FAERS)

25,247 reports across the top reactions. These are spontaneously reported events from the FDA Adverse Event Reporting System — they reflect reporting volume, not incidence or frequency, and a report does not mean the drug caused the event.

death

7,928

visual impairment

2,094

off label use

1,620

blindness

1,471

🇺🇸 Also approved in the US (FDA)

PAVBLU — AMGEN INC, approved 2026-04-28 (BLA761298).

Most reported adverse events (US / FAERS)

25,247 reports across the top reactions. These are spontaneously reported events from the FDA Adverse Event Reporting System — they reflect reporting volume, not incidence or frequency, and a report does not mean the drug caused the event.

death

7,928

visual impairment

2,094

off label use

1,620

blindness

1,471

endophthalmitis

1,405

visual acuity reduced

1,269

eye pain

1,216

drug ineffective

1,199

vision blurred

1,195

product dose omission issue

1,125

blindness unilateral

1,081

blindness transient

1,037

eye inflammation

998

eye haemorrhage

817

vitreous floaters

792