Aflibercept BS NIT
Aflibercept biosimilar developed by Fuji Pharma. Reference product Eylea.
Brands by market: Aflibercept BS NIT (Japan) · Commercial partner or holder: Fuji Pharma
FDAnot listed
EMAnot listed
PMDASep 2025approved
HCnot listed
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union
Not listed by EMA.
PMDA
Japan · Aflibercept BS NIT
Pharmaceuticals and Medical Devices Agency and MHLWApprovedBrand
Aflibercept BS NIT
Holder or applicant
Fuji Pharma
Pathway
Biosimilar (MHLW approval on PMDA review)
Approved
Sep 2025
Indications as licensed
Wet AMD, RVO macular oedema, myopic CNV
Presentations
40 mg/mL solution and kit
Note
Aflibercept Biosimilar 2.
Source
S020
HC
Canada
Not listed by HC.
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- PMDASep 2025Approved by MHLW
Sources
S020PMDA, list of approved biosimilar products in Japan (as of July 2026) Primary (regulator)
Planning aflibercept biosimilar development?
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