Home/Biosimilar Atlas/Pegfilgrastim/Pelmeg / Cegfila

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) · Company profile
FDANot listed
EMANov 2018authorised
MHRALicenseddate not shown
PMDANot listed
HCNot listed
CDSCONot listed
EDENot listed
Approved or registered in 2 of 7 markets
Connections
PegfilgrastimmoleculeCinfa Biotechdeveloper2 of 7markets2trials behind it0other products, same developer7rival developers in its markets

About Pelmeg / Cegfila

Pelmeg is the pegfilgrastim developed by Cinfa Biotech of Spain and sold in Europe by Mundipharma, approved in November 2018. Mundipharma later added a second name, Cegfila. It has not been filed in the United States.

Status by market

FDA

United States

Not listed by FDA.

EMA

European Union · Pelmeg

European Medicines Agency and European CommissionApproved
Brand
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) · checked Sep 2026
EMA

European Union · Cegfila

European Medicines Agency and European CommissionApproved
Brand
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
Remarks
Second Mundipharma brand, previously Pegfilgrastim Mundipharma.
Source
S017 (EMA) · checked Sep 2026
MHRA

United Kingdom · Pelmeg

Medicines and Healthcare products Regulatory AgencyApproved
Brand
Pelmeg
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
6 mg syringe
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.

Trials behind this product

Comparative trials on ClinicalTrials.gov matched to Pelmeg / Cegfila by development code, brand or developer. Registry data, sponsor-entered.

CandidateDeveloper or sponsorReference productPhaseDesignRegistry statusStartedPrimary completionRegistry record
B12019Cinfa BiotechNeulastaPhase 1Comparative PKCompletedNov 2015Jul 2016NCT02629562
B12019Cinfa BiotechNeulastaPhase 1Comparative PKCompletedSep 2016May 2017NCT02912377

Other developers in the same markets

Where Pelmeg / Cegfila holds an approval, these are the other pegfilgrastim biosimilars approved in that market.

MarketRivalsDevelopers (product)
EMA7Biocon Biologics (Fulphila / Vivlipeg / Biopegfil), CuraTeQ Biologics (Dyrupeg / Cavoley), Fresenius Kabi (Stimufend), Intas Pharmaceuticals (Pelgraz / Ennumo), Juta Pharma (Grasustek), Pfizer (Nyvepria), Sandoz (Ziextenzo)
MHRA5Biocon Biologics (Fulphila / Vivlipeg / Biopegfil), CuraTeQ Biologics (Dyrupeg / Cavoley), Intas Pharmaceuticals (Pelgraz / Ennumo), Juta Pharma (Grasustek), Sandoz (Ziextenzo)

Chronology

Sources

All pegfilgrastim biosimilars

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Data current to September 2026.