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Brands by market: Udenyca and Udenyca Onbody (USA); Udenyca (EU, withdrawn) · Commercial partner or holder: Accord BioPharma (current US applicant)
FDANov 2018approved
EMAwithdrawn
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States · Udenyca
US Food and Drug AdministrationApprovedBrand
Udenyca
Holder or applicant
Accord BioPharma Inc.
Pathway
351(k)
Approved
Nov 2018
Application or permission
761039
Licence type
351(k) biosimilar, not interchangeable
Presentations
6 mg/0.6 mL PFS; on-body injector (Udenyca Onbody, December 2023)
Source
S001, S016
EMA
European Union · Udenyca
European Medicines Agency and European CommissionWithdrawnBrand
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Withdrawn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
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- FDANov 2018Approved by FDA as Udenyca
- EMAFeb 2021Udenyca authorisation withdrawn
Sources
S001FDA, Biosimilar Product Information (approved biosimilars table) Primary (regulator)S016FDA Purple Book, monthly data downloads January to August 2026 Primary (regulator)S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)
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