Baiama (aflibercept)
- Region
- 🇪🇺 EU
- Active substance
- aflibercept
- Company
- Formycon AG
- Status
- Authorised
- Therapeutic area
- Wet Macular Degeneration; Macular Edema; Retinal Vein Occlusion; Choroidal Neovascularization; Diabetes Complications
- CHMP opinion
- Thu 14 Nov 2024
- EU approval
- Mon 13 Jan 2025
- Designations
- Biosimilar, Additional monitoring
- Application
- EMEA/H/C/005980
- ATC
- S01LA05
- Official record
- www.ema.europa.eu
Indication
Baiama 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
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Eydenzelt Authorised · Celltrion Healthcare Hungary Kft.
- 🇪🇺 Ahzantive 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
- 🇪🇺 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.