Pharmacokinetic, pharmacodynamic, immunogenicity, and safety study of BP14 (pegfilgrastim biosimilar) in healthy volunteers

BP14 refers to a recently approved biosimilar of the reference product Neulasta^®. This study was conducted to assess the pharmacokinetic and pharmacodynamic similarity between BP14 and Neulasta^®.

This randomized, double-blind, two-period crossover study was conducted in healthy male participants. Each participant received a single dose of 6 mg on day 1 on each treatment period and followed up for pharmacokinetics (PK), pharmacodynamics (PD), safety, and immunogenicity assessments. Primary PK endpoints were C_max and AUC_0–t while absolute neutrophil count (ANC) AUC_0–t and ANC E_max were PD endpoints. The total study duration was approximately 16 weeks including 4 weeks of screening period.

A total of 184 participants were randomized, with 92 participants in each treatment sequence. Baseline characteristics were well balanced between two groups. For primary PK endpoints, the ratio of geometric means (GMR; 90% confidence interval (CI)) for the ratio of BP14:Neulasta^® for C_max and AUC_0–t was 106.55 (98.92, 114.78) and 109.27 (100.92, 118.31), respectively, demonstrating bioequivalence between BP14 and Neulasta^®. Similarly, for PD endpoints, the GMR (95% CI) for the ratio of BP14:Neulasta^® for ANC E_max and ANC AUC_0–t was 100.32 (98.53, 102.15) and 101.06 (99.35, 102.80), respectively, demonstrating PD similarity with the acceptable criteria of 90–111%. No significant differences in terms of safety and immunogenicity were observed.

Overall, BP14 was found to be clinically similar to reference product Neulasta^® for PK and PD profiles in healthy participants. In addition, BP14 was found to be comparable to Neulasta^® in terms of safety and immunogenicity profile.

CTRI/2023/06/054223.