Pavblu
Aflibercept biosimilar developed by Amgen, development code ABP 938. Reference product Eylea.
Brands by market: Pavblu (USA, EU); Skojoy (EU, application withdrawn) · Commercial partner or holder: Amgen · Company profile
FDAAug 2024approved
EMAApr 2025authorised
MHRALicenseddate not shown
PMDANot listed
HCJul 2025approved
CDSCONot listed
EDENot listed
Approved or registered in 4 of 7 markets
Connections
About Pavblu
Pavblu is Amgen's aflibercept, approved in the United States in August 2024 and the first aflibercept biosimilar to launch there, in late 2024, after a court ruled it did not infringe the originator's patents. Europe approved it in April 2025 and Canada in July. Amgen withdrew a second European name, Skojoy, in 2025.
Status by market
FDA
United States · Pavblu
US Food and Drug AdministrationApprovedBrand
Pavblu
Holder or applicant
Amgen Inc.
Pathway
351(k)
Approved
Aug 2024
Application or permission
761298
Licence type
351(k) biosimilar, not interchangeable
Reference product in the Purple Book
Eylea
Marketing status (Purple Book)
Prescription, marketed
Presentations
2 mg/0.05 mL vial and PFS
Remarks
First aflibercept biosimilar launched in the US, October 2024.
Source
S001 (FDA); S016 (FDA Purple Book) · checked Sep 2026
EMA
European Union · Pavblu
European Medicines Agency and European CommissionApprovedBrand
Pavblu
Holder or applicant
Amgen Technology (Ireland) UC
Pathway
Centralised (Article 10(4))
Approved
Apr 2025
Application or permission
EMEA/H/C/006339
Presentations
see SmPC
Remarks
Authorisation date from the European Commission decision as reported; EMA's data table leaves it blank.
Source
S017 (EMA) · checked Sep 2026
EMA
European Union · Skojoy
European Medicines Agency and European CommissionWithdrawnBrand
Skojoy
Holder or applicant
Amgen Technology (Ireland) UC
Pathway
Centralised (Article 10(4))
Approved
not published
Application or permission
EMEA/H/C/006551
Withdrawn
Mar 2025
Presentations
see SmPC
Remarks
Application withdrawn after opinion, 4 March 2025.
Source
S017 (EMA) · checked Sep 2026
MHRA
United Kingdom · Pavblu
Medicines and Healthcare products Regulatory AgencyApprovedBrand
Pavblu
Holder or applicant
Not shown in the MHRA substance list
Pathway
UK marketing authorisation (Great Britain and, for EU-converted licences, Northern Ireland)
Approved
not published
Presentations
40 mg/mL vial and syringe
Source
S023 (MHRA Products) · checked Sep 2026
PMDA
Japan
Not listed by PMDA.
HC
Canada · Pavblu
Health CanadaApprovedBrand
Pavblu
Holder or applicant
Amgen Canada INC
Pathway
Biosimilar biologic drug (Notice of Compliance)
Approved
Jul 2025
Application or permission
DIN 02550636
Presentations
2 mg
Source
S022 (Health Canada) · checked Sep 2026
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Other developers in the same markets
Where Pavblu holds an approval, these are the other aflibercept biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| FDA | 5 | Biocon Biologics (Yesafili), Celltrion (Eydenzelt), Formycon (Ahzantive / Baiama), Samsung Bioepis (Opuviz), Sandoz (Enzeevu / Afqlir) |
| EMA | 8 | Alteogen (Eyluxvi), Alvotech (Afiveg / Mynzepli), Biocon Biologics (Yesafili), Celltrion (Eydenzelt), Formycon (Ahzantive / Baiama), Sam Chun Dang Pharm (Eiyzey / Vgenfli), Samsung Bioepis (Opuviz), Sandoz (Enzeevu / Afqlir) |
| MHRA | 7 | Alvotech (Afiveg / Mynzepli), Biocon Biologics (Yesafili), Celltrion (Eydenzelt), Formycon (Ahzantive / Baiama), Sam Chun Dang Pharm (Eiyzey / Vgenfli), Samsung Bioepis (Opuviz), Sandoz (Enzeevu / Afqlir) |
| HC | 4 | Apotex (Aflivu), Biocon Biologics (Yesafili), Celltrion (Eydenzelt), Sandoz (Enzeevu / Afqlir) |
Same developer, other molecules
Other biosimilars in the Atlas developed by Amgen: Amjevita / Amgevita, Avsola, Bkemv / Bekemv, Kanjinti, Mvasi, Riabni, Wezlana / Wezenla.
Chronology
- FDAAug 2024Approved by FDA as Pavblu
- EMAMar 2025Skojoy authorisation withdrawn
- EMAApr 2025Authorised by the European Commission as Pavblu
- HCJul 2025Notice of Compliance, Health Canada as Pavblu
Sources
S001FDA, Biosimilar Product Information (approved biosimilars table) Primary (regulator)S016FDA Purple Book, monthly data downloads January to August 2026 Primary (regulator)S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)S022Health Canada, Drug Product Database data extract (active and inactive product files, biosimilar table) Primary (regulator)S023MHRA Products, substance lists of licensed medicines (products.mhra.gov.uk) Primary (regulator)
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