Pelmeg / Cegfila
Pegfilgrastim biosimilar developed by Cinfa Biotech, development code B12019. Reference product Neulasta.
Brands by market: Pelmeg and Cegfila (EU) · Commercial partner or holder: Mundipharma (EU)
FDAnot listed
EMANov 2018authorised
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union · Pelmeg
European Medicines Agency and European CommissionApprovedBrand
Pelmeg
Holder or applicant
Mundipharma Corporation (Ireland) Limited
Pathway
Centralised (Article 10(4))
Approved
Nov 2018
Application or permission
EMEA/H/C/004700
Indications as licensed
Neutropenia in cytotoxic chemotherapy
Presentations
see SmPC
Source
S017
EMA
European Union · Cegfila
European Medicines Agency and European CommissionApprovedBrand
Cegfila
Holder or applicant
Mundipharma Corporation (Ireland) Limited
Pathway
Centralised (Article 10(4))
Approved
Dec 2019
Application or permission
EMEA/H/C/005312
Presentations
see SmPC
Note
Second Mundipharma brand, previously Pegfilgrastim Mundipharma.
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- EMANov 2018Authorised by the European Commission as Pelmeg
- EMADec 2019Authorised by the European Commission as Cegfila
Sources
S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)
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