NIVESTYM Clinical Data in Support of Biosimilarity

Data in healthy volunteers in support of biosimilarity
Multidose, crossover study to assess pharmacodynamic (PD) similarity in healthy volunteers (N=60)
NIVESTYM PD Study Description2
  • This was a randomized, open-label, multidose crossover study evaluating the PD equivalence following subcutaneous (SC) administration of NIVESTYM and Neupogen in healthy volunteers
  • The study was conducted at a single Phase 1 unit in the US
Primary endpoint: All subjects who completed the study and had sufficient data to calculate the primary PD variables (AUECCD34+ and CD34+max) were included in the PD population. Sufficient data were defined as having more than 3 measurable values in addition to the pre-dose samples and 120-hour sample, such that the primary endpoints could be reliably calculated. The PD population was the primary analysis set for the primary PD analyses.
Secondary endpoint: The secondary PD variable was the time to maximum observed CD34+ count (Tmax[CD34+]).
AUECCD34+=area under the effect curve for CD34+ count; CD34+max=maximum observed CD34+ count;
Tmax(CD34+)=time to maximum observed CD34+ count.
 
NIVESTYM PD Study Design2
Subjects administered study medication for 5 consecutive days at a dose of 5 mcg/kg/day.
 
NIVESTYM PD Study Results
PD analysis established equivalence to Neupogen in support of biosimilarity2
Primary PD endpoint of CD34+ cells for PD population was similar across treatments.
PD population: n=56.
PD equivalence was concluded if the 90% CIs for both AUECCD34+ and CD34+max were completely contained within the prespecified acceptance limits.