Home/Biosimilar Atlas/Pegfilgrastim/Dyrupeg / Cavoley

Dyrupeg / Cavoley

Pegfilgrastim biosimilar developed by CuraTeQ Biologics (Aurobindo). Reference product Neulasta.

Brands by market: Dyrupeg (EU); Cavoley (EU, positive opinion July 2026) · Commercial partner or holder: CuraTeQ Biologics · Company profile
FDANot listed
EMAMar 2025authorised
MHRALicenseddate not shown
PMDANot listed
HCNot listed
CDSCONot listed
EDENot listed
Approved or registered in 2 of 7 markets
Connections
PegfilgrastimmoleculeCuraTeQ Biologicsdeveloper2 of 7markets0trials behind it3other products, same developer7rival developers in its markets

About Dyrupeg / Cavoley

Dyrupeg is CuraTeQ's pegfilgrastim, approved in Europe in March 2025 after an earlier application under the same name was withdrawn and refiled. CuraTeQ, the biologics arm of Aurobindo, received a positive opinion for a second name, Cavoley, in July 2026. With its filgrastim and trastuzumab, it gives CuraTeQ three European antibodies and growth factors.

Status by market

FDA

United States

Not listed by FDA.

EMA

European Union · Dyrupeg

European Medicines Agency and European CommissionApproved
Brand
Dyrupeg
Holder or applicant
CuraTeQ Biologics (Malta) Limited
Pathway
Centralised (Article 10(4))
Approved
Mar 2025
Application or permission
EMEA/H/C/006407
Presentations
see SmPC
Remarks
An earlier application under the same name was withdrawn.
Source
S017 (EMA) · checked Sep 2026
EMA

European Union · Cavoley

European Medicines Agency and European CommissionUnder review
Brand
Cavoley
Holder or applicant
CuraTeQ Biologics s.r.o
Pathway
Centralised (Article 10(4))
Status
CHMP positive opinion Jul 2026; European Commission decision pending
Presentations
see SmPC
Remarks
CHMP positive opinion 23 July 2026; Commission decision pending.
Source
S017 (EMA) · checked Sep 2026
MHRA

United Kingdom · Dyrupeg

Medicines and Healthcare products Regulatory AgencyApproved
Brand
Dyrupeg
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.

Other developers in the same markets

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

MarketRivalsDevelopers (product)
EMA7Biocon Biologics (Fulphila / Vivlipeg / Biopegfil), Cinfa Biotech (Pelmeg / Cegfila), Fresenius Kabi (Stimufend), Intas Pharmaceuticals (Pelgraz / Ennumo), Juta Pharma (Grasustek), Pfizer (Nyvepria), Sandoz (Ziextenzo)
MHRA5Biocon Biologics (Fulphila / Vivlipeg / Biopegfil), Cinfa Biotech (Pelmeg / Cegfila), Intas Pharmaceuticals (Pelgraz / Ennumo), Juta Pharma (Grasustek), Sandoz (Ziextenzo)

Same developer, other molecules

Other biosimilars in the Atlas developed by CuraTeQ Biologics: CuraTeQ bevacizumab, Dazublys / CuraTeQ trastuzumab, Zefylti.

Chronology

Sources

All pegfilgrastim biosimilars

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Data current to September 2026.