Afqlir (aflibercept)
BiosimilarAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- aflibercept
- Company
- Sandoz GmbH
- 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, Additional monitoring
- Application
- EMEA/H/C/006150
- ATC
- S01LA05
- Official record
- www.ema.europa.eu
Indication
Afqlir 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.
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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.