UDENYCA® was confirmed to be highly similar to Neulasta® (pegfilgrastim), with no clinically meaningful differences.1,2
* The assays used to assess immunogenicity for UDENYCA were highly sensitive and demonstrated no treatment-emergent neutralizing antibodies in more than 300 subjects.
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 variability compared to 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 response
- Lack of confounding factors in healthy subjects allows for better evaluation of treatment-related adverse events that are specific to pegfilgrastim
Clinical studies in cancer patients to confirm biosimilarity of UDENYCA to Neulasta® were not required by the FDA.
ADA = antidrug antibody; adverse events = AE; PK/PD = pharmacokinetic/pharmacodynamic.
Establishing biosimilarity for UDENYCA
The FDA recommends a stepwise approach for biosimilar development3,4
THREE ADMINISTRATION OPTIONS
UDENYCA offers multiple administration options so you can prescribe based on the needs of your patients.
RECOMMENDATIONS FOR USE
Practice guidelines suggest pegfilgrastim use in appropriate patients to support clinical outcomes during chemotherapy.5
ACCESS & SUPPORT
UDENYCA SolutionsTM provides patient support services designed to remove hurdles to access UDENYCA®
