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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 · Company profile
FDANot listed
EMANot listed
MHRANot listed
PMDASep 2025approved
HCNot listed
CDSCONot listed
EDENot listed
Approved or registered in 1 of 7 markets
Connections
AfliberceptmoleculeFuji Pharmadeveloper1 of 7markets0trials behind it4other products, same developer3rival developers in its markets

About Aflibercept BS NIT

Aflibercept BS NIT is Fuji Pharma's aflibercept, approved in Japan in September 2025, the second aflibercept biosimilar there. Fuji Pharma 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 NIT

Pharmaceuticals and Medical Devices Agency and MHLWApproved
Brand
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
Remarks
Aflibercept Biosimilar 2.
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 NIT holds an approval, these are the other aflibercept biosimilars approved in that market.

MarketRivalsDevelopers (product)
PMDA3Celltrion (Eydenzelt), Global Regulatory Partners (Aflibercept BS GRP), Sam Chun Dang Pharm (Eiyzey / Vgenfli)

Same developer, other molecules

Other biosimilars in the Atlas developed by Fuji Pharma: Denosumab BS F, Filgrastim BS F / Mochida, Golimumab BS F, Ustekinumab BS F.

Chronology

Sources

All aflibercept biosimilars

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Data current to September 2026.