Aflibercept BS GRP
Aflibercept biosimilar developed by Global Regulatory Partners. Reference product Eylea.
Brands by market: Aflibercept BS GRP (Japan) · Commercial partner or holder: Global Regulatory Partners
FDAnot listed
EMAnot listed
PMDAJun 2024approved
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 GRP
Pharmaceuticals and Medical Devices Agency and MHLWApprovedBrand
Aflibercept BS GRP
Holder or applicant
Global Regulatory Partners
Pathway
Biosimilar (MHLW approval on PMDA review)
Approved
Jun 2024
Indications as licensed
RVO macular oedema, myopic CNV, DME
Presentations
40 mg/mL intravitreal solution
Note
Aflibercept Biosimilar 1, the first in Japan.
Source
S020
HC
Canada
Not listed by HC.
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- PMDAJun 2024Approved by MHLW
Sources
S020PMDA, list of approved biosimilar products in Japan (as of July 2026) Primary (regulator)
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