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
FDAnot listed
EMAMar 2025authorised
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union · Dyrupeg
European Medicines Agency and European CommissionApprovedBrand
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
Note
An earlier application under the same name was withdrawn.
Source
S017
EMA
European Union · Cavoley
European Medicines Agency and European CommissionUnder reviewBrand
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
Note
CHMP positive opinion 23 July 2026; Commission decision pending.
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- EMAMar 2025Authorised by the European Commission as Dyrupeg
- EMAJul 2026CHMP positive opinion for Cavoley
Sources
S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)
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