UDENYCA® provides the established outcomes you expect for your patients

UDENYCA® was confirmed to be highly similar to Neulasta® (pegfilgrastim), with no clinically meaningful differences.1,2

Biosimilars list
Approval based on extensive data analysis and stringent FDA requirements3

Clinical studies with UDENYCA® were conducted in healthy subjects, the most sensitive and informative population in which to assess biosimilarity.4

  • A study in healthy subjects is likely to produce less pharmacokinetic/pharmacodynamic (PK/PD) variability compared with a study in patients with potential confounding factors such as underlying and/or concomitant disease and concomitant medications such as myelosuppressive chemotherapy
  • Healthy subjects are fully immunocompetent and can mount an immune antidrug antibody (ADA) response
  • Lack of confounding factors in healthy subjects allows for better evaluation of treatment-related adverse events (AEs) that are specific to pegfilgrastim

Clinical studies in cancer patients to confirm biosimilarity of UDENYCA® to Neulasta® were not required by the FDA.

Establishing biosimilarity for UDENYCA®

The FDA recommends a stepwise approach
for biosimilar development3,4

Reference product
Biosimilar development
Reference product
  • The stepwise approach for biosimilars is different from the developmental model used for reference products, in which clinical trial data in the intended patient population provide the basis for approval3
Biosimilar development
  • In the biosimilar development paradigm, the analytical assessment forms the foundation of the totality of evidence, and the nonclinical data, together with pharmacokinetics/ pharmacodynamics (PK/PD), immunogenicity, and safety data, support the demonstration of biosimilarity3

UDENYCA® is dosed and administered identically to Neulasta® PFS.1,2

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UDENYCA Solutions™ provides a suite of patient support services, programs, and industry-leading electronic services designed to assist with patient access.


References: 1. UDENYCA® (pegfilgrastim-cbqv) Prescribing Information. Redwood City, CA: Coherus BioSciences, Inc.; 2023. 2. Neulasta® (pegfilgrastim) Prescribing Information. Thousand Oaks, CA: Amgen Inc.; 2021. 3. Scientific considerations in demonstrating biosimilarity to a reference product: guidance for industry. US Food and Drug Administration. Published April 2015. Updated April 24, 2020. Accessed April 27, 2023. https://www.fda.gov/media/82647/download. 4. Clinical pharmacology data to support a demonstration of biosimilarity to a reference product: guidance for industry. US Food and Drug Administration. Published December 2016. Accessed April 27, 2023. https://www.fda.gov/media/88622/download.