Nylaspeg
Pegfilgrastim biosimilar developed by Qilu Pharmaceutical. Reference product Neulasta.
About Nylaspeg
Nylaspeg is Qilu's pegfilgrastim. The European committee gave a positive opinion in June 2026 and the Commission's decision is awaited. It follows Qilu's ranibizumab, Rimmyrah, as the Chinese company's second European biosimilar.
Status by market
United States
Not listed by FDA.
European Union · Nylaspeg
European Medicines Agency and European CommissionUnder reviewUnited Kingdom
Not listed by MHRA.
Japan
Not listed by PMDA.
Canada
Not listed by HC.
India
Not listed by CDSCO.
United Arab Emirates
Not listed by EDE.
Trials behind this product
Comparative trials on ClinicalTrials.gov matched to Nylaspeg by development code, brand or developer. Registry data, sponsor-entered.
| Candidate | Developer or sponsor | Reference product | Phase | Design | Registry status | Started | Primary completion | Registry record |
|---|---|---|---|---|---|---|---|---|
| QL0605 | Qilu Pharmaceutical | Neulasta | Phase 1 | Comparative PK | Unknown, last recruiting | Nov 2020 | Nov 2021 | NCT04651036 |
Same developer, other molecules
Other biosimilars in the Atlas developed by Qilu Pharmaceutical: Rimmyrah.
Chronology
- EMAJun 2026CHMP positive opinion for Nylaspeg
Sources
S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)
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