Home/Biosimilar Atlas/Epoetin alfa and zeta/Binocrit / Epoetin alfa Hexal / Abseamed

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) · Company profile
FDANot listed
EMAAug 2007authorised
MHRALicenseddate not shown
PMDANot listed
HCNot listed
CDSCONot listed
EDESep 2018registered
Approved or registered in 3 of 7 markets
Connections
Epoetin alfa and zetamoleculeSandozdeveloper3 of 7markets0trials behind it9other products, same developer1rival developers in its markets

About Binocrit / Epoetin alfa Hexal / Abseamed

Sandoz's epoetin alfa was the first epoetin biosimilar approved in Europe, in August 2007, under three names for three Sandoz group companies: Binocrit, Epoetin alfa Hexal and Abseamed. Binocrit is registered in the UAE in six strengths. Sandoz has not filed it in the United States.

Status by market

FDA

United States

Not listed by FDA.

EMA

European Union · Binocrit

European Medicines Agency and European CommissionApproved
Brand
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
Remarks
First EU epoetin biosimilar.
Source
S017 (EMA) · checked Sep 2026
EMA

European Union · Epoetin alfa Hexal

European Medicines Agency and European CommissionApproved
Brand
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
Remarks
Duplicate authorisation.
Source
S017 (EMA) · checked Sep 2026
EMA

European Union · Abseamed

European Medicines Agency and European CommissionApproved
Brand
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
Remarks
Duplicate authorisation.
Source
S017 (EMA) · checked Sep 2026
MHRA

United Kingdom · Abseamed

Medicines and Healthcare products Regulatory AgencyApproved
Brand
Abseamed
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
1,000 to 40,000 IU syringes
Source
S023 (MHRA Products) · checked Sep 2026
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 EstablishmentRegistered
Brand
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 (UAE Emirates Drug Establishment) · checked Sep 2026

Other developers in the same markets

Where Binocrit / Epoetin alfa Hexal / Abseamed holds an approval, these are the other epoetin alfa and zeta biosimilars approved in that market.

MarketRivalsDevelopers (product)
EMA1Norbitec (Retacrit / Silapo)
MHRA1Norbitec (Retacrit / Silapo)

Same developer, other molecules

Other biosimilars in the Atlas developed by Sandoz: Enzeevu / Afqlir, Erelzi, Hyrimoz / Hefiya, Inclunox, Jubbonti / Wyost, Omnitrope, Rixathon / Riximyo, Zarxio / Zarzio, Ziextenzo.

Chronology

Sources

All epoetin alfa and zeta biosimilars

Planning epoetin alfa and zeta 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 consultant
Data current to September 2026.