Nylaspeg
Pegfilgrastim biosimilar developed by Qilu Pharmaceutical. Reference product Neulasta.
Brands by market: Nylaspeg (EU, positive opinion June 2026) · Commercial partner or holder: Qilu Pharma Spain
FDAnot listed
EMAunder review
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union · Nylaspeg
European Medicines Agency and European CommissionUnder reviewBrand
Nylaspeg
Holder or applicant
Qilu Pharma Spain S.L.
Pathway
Centralised (Article 10(4))
Status
CHMP positive opinion Jun 2026; European Commission decision pending
Presentations
see SmPC
Note
CHMP positive opinion 25 June 2026; Commission decision pending.
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- EMAJun 2026CHMP positive opinion for Nylaspeg
Sources
S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)
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