UDENYCA® provides the established outcomes you expect
UDENYCA® was confirmed to be highly similar to Neulasta® (pegfilgrastim), with no clinically meaningful differences.1-3
Clinical studies with UDENYCA® were conducted in healthy subjects, the most sensitive and informative population in which to assess biosimilarity.5
- 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.
References: 1. UDENYCA® (pegfilgrastim-cbqv) package insert. Redwood City, CA: Coherus BioSciences, Inc.; 2019. 2. Data on file. Coherus BioSciences, Inc.; 2021. 3. Neulasta® (pegfilgrastim) package insert. Thousand Oaks, CA: Amgen Inc.; 2020. 4. 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 May 19, 2020. https://www.fda.gov/media/82647/download 5. 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 June 1, 2020. https://www.fda.gov/media/88622/download