Opuviz (aflibercept)
Biosimilar
- Region
- 🇪🇺 EU
- Active substance
- aflibercept
- Company
- Samsung Bioepis NL B.V.
- Status
- Authorised
- Therapeutic area
- Wet Macular Degeneration; Macular Edema; Diabetes Complications; Retinal Vein Occlusion
- CHMP opinion
- Thu 19 Sep 2024
- EU approval
- Wed 13 Nov 2024
- Designations
- Biosimilar
- Application
- EMEA/H/C/006056
- ATC
- S01LA05
- Official record
- www.ema.europa.eu
Indication
Opuviz 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
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- 🇪🇺 Mynzepli Authorised · Advanz Pharma Limited
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- 🇪🇺 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.