Home/Biosimilar Atlas/Pegfilgrastim/Udenyca

Udenyca

Pegfilgrastim biosimilar developed by Coherus BioSciences, development code CHS-1701. Reference product Neulasta.

Brands by market: Udenyca and Udenyca Onbody (USA); Udenyca (EU, withdrawn) · Commercial partner or holder: Accord BioPharma (current US applicant) · Company profile
FDANov 2018approved
EMAWithdrawn
MHRANot listed
PMDANot listed
HCNot listed
CDSCONot listed
EDENot listed
Approved or registered in 1 of 7 markets
Connections
PegfilgrastimmoleculeCoherus BioSciencesdeveloper1 of 7markets0trials behind it1other products, same developer7rival developers in its markets

About Udenyca

Udenyca was developed by Coherus BioSciences and approved in the United States in November 2018, where it became one of the best-selling pegfilgrastim biosimilars. In 2023 it added Udenyca Onbody, the first biosimilar with an on-body injector matching the originator's device. A European approval in 2018 was withdrawn in 2021 without launch. Coherus sold the product in 2024, and Accord now holds the US licence.

Status by market

FDA

United States · Udenyca

US Food and Drug AdministrationApproved
Brand
Udenyca
Holder or applicant
Accord BioPharma Inc.
Pathway
351(k)
Approved
Nov 2018
Application or permission
761039
Licence type
351(k) biosimilar, not interchangeable
Reference product in the Purple Book
Neulasta
Marketing status (Purple Book)
Prescription, marketed
Presentations
6 mg/0.6 mL PFS; on-body injector (Udenyca Onbody, December 2023)
Source
S001 (FDA); S016 (FDA Purple Book) · checked Sep 2026
EMA

European Union · Udenyca

European Medicines Agency and European CommissionWithdrawn
Brand
Udenyca
Holder or applicant
ERA Consulting GmbH
Pathway
Centralised (Article 10(4))
Approved
Sep 2018
Application or permission
EMEA/H/C/004413
Withdrawn
Feb 2021
Presentations
see SmPC
Source
S017 (EMA) · checked Sep 2026
MHRA

United Kingdom

Not listed by MHRA.

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 Udenyca holds an approval, these are the other pegfilgrastim biosimilars approved in that market.

MarketRivalsDevelopers (product)
FDA7Biocon Biologics (Fulphila / Vivlipeg / Biopegfil), Fresenius Kabi (Stimufend), Intas Pharmaceuticals (Pelgraz / Ennumo), Kashiv BioSciences (Fylnetra), Lupin (Armlupeg / Lupin pegfilgrastim), Pfizer (Nyvepria), Sandoz (Ziextenzo)

Same developer, other molecules

Other biosimilars in the Atlas developed by Coherus BioSciences: Yusimry.

Chronology

Sources

All pegfilgrastim biosimilars

Planning pegfilgrastim biosimilar development?

EvySaif can help assess your regulatory pathway, clinical evidence requirements and market-entry strategy across India, UAE and other target markets.

Talk to a biosimilar regulatory consultant
Data current to September 2026.