Mynzepli (aflibercept)
BiosimilarAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- aflibercept
- Company
- Advanz Pharma Limited
- Status
- Authorised
- Therapeutic area
- Wet Macular Degeneration; Macular Edema; Diabetes Complications; Retinal Vein Occlusion; Choroidal Neovascularization
- CHMP opinion
- Thu 19 Jun 2025
- EU approval
- Mon 18 Aug 2025
- Designations
- Biosimilar, Additional monitoring
- Application
- EMEA/H/C/006438
- ATC
- S01LA05
- Official record
- www.ema.europa.eu
Indication
Mynzepli is indicated for adults for the treatment of- neovascular (wet) age-related macular degeneration (AMD),- visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO),- visual impairment due to diabetic macular oedema (DME),- visual impairment due to myopic choroidal neovascularisation (myopic CNV)
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Eydenzelt Authorised · Celltrion Healthcare Hungary Kft.
- 🇪🇺 Ahzantive Authorised · Formycon AG
- 🇪🇺 Baiama Authorised · Formycon AG
- 🇪🇺 Afqlir Authorised · Sandoz GmbH
- 🇪🇺 Opuviz Authorised · Samsung Bioepis NL B.V.
- 🇪🇺 Yesafili Authorised · Biosimilar Collaborations Ireland Limited
- 🇪🇺 Pavblu Authorised · Amgen Technology (Ireland) UC
- 🇪🇺 Afiveg Authorised · STADA Arzneimittel AG
- 🇪🇺 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
Follow Mynzepli
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
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.