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