Pavblu (aflibercept)
- Region
- 🇪🇺 EU
- Active substance
- aflibercept
- Company
- Amgen Technology (Ireland) UC
- Status
- Authorised
- Therapeutic area
- Wet Macular Degeneration; Macular Edema; Retinal Vein Occlusion; Choroidal Neovascularization; Diabetes Complications
- CHMP opinion
- Thu 30 Jan 2025
- Designations
- Biosimilar, Additional monitoring
- Application
- EMEA/H/C/006339
- ATC
- S01LA05
- Official record
- www.ema.europa.eu
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 neovascularisation (myopic CNV) (see section 5.1).
Regulatory milestones
FDA approves biosimilar Pavblu (aflibercept-ayyh)
Same substance in other markets
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- 🇪🇺 Opuviz Authorised · Samsung Bioepis NL B.V.
- 🇪🇺 Yesafili Authorised · Biosimilar Collaborations Ireland Limited
- 🇪🇺 Afiveg Authorised · STADA Arzneimittel AG
- 🇪🇺 Mynzepli Authorised · Advanz Pharma Limited
- 🇪🇺 Eyluxvi Authorised · Biolitec pharma Limited Zweigniederlassung Jena
- 🇪🇺 Vgenfli Authorised · Zaklady FarmaFarmaceutyczne Polpharma S.Aceutyczne Polpharma S.A.
- 🇪🇺 Eiyzey Authorised · Zaklady FarmaFarmaceutyczne Polpharma S.Aceutyczne Polpharma S.A.
- 🇪🇺 Eylea Authorised · Bayer AG
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.