Immunogenicity (anti-drug antibody; ADA) data is presented for all subjects' samples collected and a descriptive analysis is provided for immunogenicity (ADA) data.

Percentage incidence within + 10% of the expected ADA positivity incidence of Test (6% ADA in Test is anticipated from literature) is not considered clinically significant.

Evaluation of immunogenicity is carried out in a tiered fashion:

1. Screening assay to assess if samples were positive or negative for anti-PegG-CSF.
2. Confirmatory assays for samples that were positive in the screening assay. The confirmatory assays assessed if antibodies were specific for INTP5, Neulasta, PEG and/or filgrastim.
3. Titer assay was performed to determine titer of the anti-PEG-GCSF antibody samples.
4. Neutralizing antibody (NAb) assay for those samples that were positive in the confirmatory assays to assess the neutralizing capability of the antibody to inhibit pegfilgrastim activity.

Pharmacokinetic (PK) properties of the test and reference formulations were assessed by measuring serum Pegfilgrastim concentration.

Maximum measured serum concentration, calculated from the serum concentration vs. time profile of the individual subjects.

All the 19 ADA confirmed positive subjects were included in the PK analysis: 10 subjects from INTP5 and 9 subjects from US-Neulasta.

Area under the serum concentration vs. time curve, calculated by linear trapezoidal rule from measured data points from the time zero to the time of last quantified concentration.

All the 19 ADA confirmed positive subjects were included in the PK analysis: 10 subjects from INTP5 and 9 subjects from US-Neulasta

Area under the serum concentration versus time curve from time zero to infinity. Where AUC[0-infinity]= AUC[0-t] + Ct/lambda-z, Ct is the last measurable concentration and lamda-z is the terminal rate constant. AUC[0-infinity] is the sum of measurable and extrapolated parts.

All the 19 ADA confirmed positive subjects were included in the PK analysis: 10 subjects from INTP5 and 9 subjects from US-Neulasta

The time of observing the peak concentration, calculated from the serum concentration vs. time profile of the individual subjects.

All the 19 ADA confirmed positive subjects were included in the PK analysis: 10 subjects from INTP5 and 9 subjects from US-Neulasta

Terminal rate constant: First order rate constant associated with the terminal (log-linear) portion of the curve. This was estimated via linear regression of time vs. log concentration. This parameter was calculated by linear least squares regression analysis using last three or more nonzero plasma concentration values.

All the 19 ADA confirmed positive subjects were included in the PK analysis: 10 subjects from INTP5 and 9 subjects from US-Neulasta

Goodness of fit statistic for the terminal phase, adjusted for the number of points used in the estimation of λz (lambda-z). R^2 is the coefficient of determination and can range from 0 to 1, with higher values indicating greater predictability.

All the 19 ADA confirmed positive subjects were included in the PK analysis: 10 subjects from INTP5 and 9 subjects from US-Neulasta

The residual area in percentage determined by the formula, [(AUC[0-infinity]-AUC[0-t])/AUC[0-infinity]] x 100.

All the 19 ADA confirmed positive subjects were included in the PK analysis: 10 subjects from INTP5 and 9 subjects from US-Neulasta

The terminal half-life calculated using the formula 0.693/(lambda-z)

All the 19 ADA confirmed positive subjects were included in the PK analysis: 10 subjects from INTP5 and 9 subjects from US-Neulasta

Maximum measured absolute neutrophil count (ANC).

Outcome Measure Data Table is breaks participants into negative-ADA or positive-ADA, totaling the overall number of participants by arm

Area under the ANC versus time curve from time zero to the last measurable concentration as calculated by linear trapezoidal method.

Outcome Measure Data Table is breaks participants into negative-ADA or positive-ADA, totaling the overall number of participants by arm

Time to reach the maximum measured absolute neutrophil count (ANC)

Table breaks participants into ADA(-) or ADA(+), totaling the overall number of participants by arm. 5 Subjects having three consecutive missing samples in elimination phase were excluded from the analysis of AUEC0-t reducing the total participants to 88 for INTP5 Dose 1, 88 for INTP5 Dose 2, 92 for Neulasta Dose 1, and 91 for Neulasta Dose 2.

Maximum measured absolute neutrophil count (ANC).

Outcome Measure Data Table is breaks participants into negative-ADA or positive-ADA, totaling the overall number of participants by arm

Area under the absolute neutrophil count (ANC) versus time curve from time zero to the last measurable concentration as calculated by linear trapezoidal method.

Outcome Measure Data Table is breaks participants into negative-ADA or positive-ADA, totaling the overall number of participants by arm

Time to reach the maximum measured absolute neutrophil count (ANC)

Outcome Measure Data Table is breaks participants into negative-ADA or positive-ADA, totaling the overall number of participants by arm

First order rate constant associated with the terminal (log-linear) portion of the curve. This was estimated via linear regression of time vs. log concentration. This parameter was calculated by linear least squares regression analysis using last three or more non-zero plasma concentration values.

Outcome Measure Data Table is breaks participants into negative-ADA or positive-ADA, totaling the overall number of participants by arm

The terminal half-life will be calculated as 0.693/(lambda-z)

Outcome Measure Data Table is breaks participants into negative-ADA or positive-ADA, totaling the overall number of participants by arm