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)
FDAMay 2018approved
EMADec 2007authorised
PMDAnot listed
HCnot listed
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States · Retacrit
US Food and Drug AdministrationApprovedBrand
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
Presentations
2,000 to 40,000 units/mL vials
Note
First epoetin biosimilar in the United States.
Source
S001, S016
EMA
European Union · Silapo
European Medicines Agency and European CommissionApprovedBrand
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
Note
Epoetin zeta.
Source
S017
EMA
European Union · Retacrit
European Medicines Agency and European CommissionApprovedBrand
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
Note
Epoetin zeta.
Source
S017
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.
Chronology
- EMADec 2007Authorised by the European Commission as Retacrit
- EMADec 2007Authorised by the European Commission as Silapo
- FDAMay 2018Approved by FDA as Retacrit
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)
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