Home/Biosimilar Atlas/Epoetin alfa and zeta/Retacrit / Silapo

Retacrit / Silapo

Epoetin alfa and zeta biosimilar developed by Norbitec (Stada and Hospira). Reference product Eprex (Epogen and Procrit in the United States).

Brands by market: Retacrit (USA, EU); Silapo (EU) · Commercial partner or holder: Stada (Silapo); Pfizer (Retacrit) · Company profile
FDAMay 2018approved
EMADec 2007authorised
MHRALicenseddate not shown
PMDANot listed
HCNot listed
CDSCONot listed
EDENot listed
Approved or registered in 3 of 7 markets
Connections
Epoetin alfa and zetamoleculeNorbitecdeveloper3 of 7markets0trials behind it0other products, same developer1rival developers in its markets

About Retacrit / Silapo

This epoetin was developed by Norbitec for Stada and Hospira and approved in Europe in December 2007 as Silapo and Retacrit. Europe gave it the separate name epoetin zeta because its sugar chains differ from the reference. In the United States, Pfizer's Hospira gained approval as Retacrit in 2018, the only epoetin biosimilar there, where it is called epoetin alfa-epbx.

Status by market

FDA

United States · Retacrit

US Food and Drug AdministrationApproved
Brand
Retacrit
Holder or applicant
Hospira Inc., a Pfizer Company
Pathway
351(k)
Approved
May 2018
Application or permission
125545
Licence type
351(k) biosimilar, not interchangeable
Reference product in the Purple Book
Procrit
Marketing status (Purple Book)
Prescription, marketed
Presentations
2,000 to 40,000 units/mL vials
Remarks
First epoetin biosimilar in the United States.
Source
S001 (FDA); S016 (FDA Purple Book) · checked Sep 2026
EMA

European Union · Silapo

European Medicines Agency and European CommissionApproved
Brand
Silapo
Holder or applicant
Stada Arzneimittel AG
Pathway
Centralised (Article 10(4))
Approved
Dec 2007
Application or permission
EMEA/H/C/000760
Indications as licensed
Anaemia of CKD, chemotherapy-induced anaemia, autologous blood predonation, elective surgery
Presentations
see SmPC
Remarks
Epoetin zeta.
Source
S017 (EMA) · checked Sep 2026
EMA

European Union · Retacrit

European Medicines Agency and European CommissionApproved
Brand
Retacrit
Holder or applicant
Pfizer Europe MA EEIG
Pathway
Centralised (Article 10(4))
Approved
Dec 2007
Application or permission
EMEA/H/C/000872
Presentations
see SmPC
Remarks
Epoetin zeta.
Source
S017 (EMA) · checked Sep 2026
MHRA

United Kingdom · Retacrit

Medicines and Healthcare products Regulatory AgencyApproved
Brand
Retacrit
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

Not listed by EDE.

Other developers in the same markets

Where Retacrit / Silapo holds an approval, these are the other epoetin alfa and zeta biosimilars approved in that market.

MarketRivalsDevelopers (product)
EMA1Sandoz (Binocrit / Epoetin alfa Hexal / Abseamed)
MHRA1Sandoz (Binocrit / Epoetin alfa Hexal / Abseamed)

Chronology

Sources

All epoetin alfa and zeta biosimilars

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Data current to September 2026.