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 · Company profile
FDANot listed
EMANot listed
MHRANot listed
PMDAJun 2024approved
HCNot listed
CDSCONot listed
EDENot listed
Approved or registered in 1 of 7 markets
Connections
About Aflibercept BS GRP
Aflibercept BS GRP was the first aflibercept biosimilar approved in Japan, in June 2024. The holder, Global Regulatory Partners, is a Japanese licensing company and has not named the developer.
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union
Not listed by EMA.
MHRA
United Kingdom
Not listed by MHRA.
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
Remarks
Aflibercept Biosimilar 1, the first in Japan.
Source
S020 (PMDA) · checked Sep 2026
HC
Canada
Not listed by HC.
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Other developers in the same markets
Where Aflibercept BS GRP holds an approval, these are the other aflibercept biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| PMDA | 3 | Celltrion (Eydenzelt), Fuji Pharma (Aflibercept BS NIT), Sam Chun Dang Pharm (Eiyzey / Vgenfli) |
Chronology
- PMDAJun 2024Approved by MHLW
Sources
S020PMDA, list of approved biosimilar products in Japan (as of July 2026) Primary (regulator)
Planning aflibercept biosimilar development?
EvySaif can help assess your regulatory pathway, clinical evidence requirements and market-entry strategy across India, UAE and other target markets.
Talk to a biosimilar regulatory consultantData current to September 2026.