UDENYCA® was confirmed to be highly similar to Neulasta® (pegfilgrastim), with no clinically meaningful differences.1,2
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The assays used to assess immunogenicity for UDENYCA were highly sensitive and demonstrated no treatment-emergent neutralizing antibodies in more than 300 subjects.
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
- 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.
Approval based on extensive data analysis and stringent FDA requirements3
Establishing biosimilarity for UDENYCA
The FDA recommends a stepwise approach for biosimilar development3,4
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