Binocrit / Epoetin alfa Hexal / Abseamed
Epoetin alfa and zeta biosimilar developed by Sandoz, development code HX575. Reference product Eprex (Epogen and Procrit in the United States).
Brands by market: Binocrit (EU, UAE); Epoetin alfa Hexal and Abseamed (EU) · Commercial partner or holder: Sandoz; Hexal; Medice (EU brands)
FDAnot listed
EMAAug 2007authorised
PMDAnot listed
HCnot listed
CDSCOnot listed
EDESep 2018registered
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union · Binocrit
European Medicines Agency and European CommissionApprovedBrand
Binocrit
Holder or applicant
Sandoz GmbH
Pathway
Centralised (Article 10(4))
Approved
Aug 2007
Application or permission
EMEA/H/C/000725
Indications as licensed
Anaemia of CKD, chemotherapy-induced anaemia, autologous blood predonation, elective surgery
Presentations
see SmPC
Note
First EU epoetin biosimilar.
Source
S017
EMA
European Union · Epoetin alfa Hexal
European Medicines Agency and European CommissionApprovedBrand
Epoetin alfa Hexal
Holder or applicant
Hexal AG
Pathway
Centralised (Article 10(4))
Approved
Aug 2007
Application or permission
EMEA/H/C/000726
Presentations
see SmPC
Note
Duplicate authorisation.
Source
S017
EMA
European Union · Abseamed
European Medicines Agency and European CommissionApprovedBrand
Abseamed
Holder or applicant
Medice Arzneimittel Pütter GmbH Co. KG
Pathway
Centralised (Article 10(4))
Approved
Aug 2007
Application or permission
EMEA/H/C/000727
Presentations
see SmPC
Note
Duplicate authorisation.
Source
S017
PMDA
Japan
Not listed by PMDA.
HC
Canada
Not listed by HC.
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates · Binocrit
Emirates Drug EstablishmentRegisteredBrand
Binocrit
Holder or applicant
Sandoz GmbH TechOps, Austria · UAE supplier Alphamed Drug Store
Pathway
Registered medical product
Registered
Sep 2018
Presentations
1,000 IU/0.5 mL to 40,000 IU/mL PFS
Source
S018
Chronology
- EMAAug 2007Authorised by the European Commission as Abseamed
- EMAAug 2007Authorised by the European Commission as Epoetin alfa Hexal
- EMAAug 2007Authorised by the European Commission as Binocrit
- EDESep 2018Registered in the UAE as Binocrit
Sources
S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)S018UAE Emirates Drug Establishment, registered medical product directory Primary (regulator)
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