A randomised, crossover study establishing pharmacokinetic and
pharmacodynamic equivalence between Lupin’s Pegfilgrastim and
Neulasta® in healthy subjects
Abstract
Aim This study aimed to demonstrate biosimilarity between Lupin’s
Pegfilgrastim versus Neulasta® with respect to
pharmacokinetic (PK), pharmacodynamic (PD), immunogenicity, and safety
profiles. Methods This double-blind, randomised, single-dose,
two-sequence, two-treatment, two-period, crossover, comparative PK and
PD study enrolled healthy subjects aged 18 to 45 years. The test product
was Lupin’s Pegfilgrastim and the reference product was U.S.-licensed
Neulasta®. Blood samples were collected at different
time points for assessment of PK, PD, and immunogenicity. Primary
objectives included comparing the relative bioavailability and the
pharmacodynamic effect of the two products. Secondary objectives
included assessing immunogenicity, safety and tolerability.
Biosimilarity was concluded if the 90% confidence interval (CI) of the
ratio of the geometric least-squares mean (LSM) for PK and PD parameters
were within 80 to 125%. Results The geometric mean ratios of Lupin’s
Pegfilgrastim and Neulasta® for primary PK parameters
were Cmax [94.37 (89.53 to 99.47%)],
AUC0-t [94.76 (89.83 to 99.95%)] and
AUC0-∞ [94.82 (89.90 to 100.02%)], and for primary
PD parameters were ANC_Cmax [100.59
(98.96-102.25%)] and ANC_AUEC0-tlast [100.51
(99.18,101.85%)]. The corresponding 90% CIs were within the
pre-defined equivalence limit of 80% and 125%. The incidence of ADA
formation was similar between patients receiving Lupin’s Pegfilgrastim
and Neulasta®. No new safety concerns were observed.
Conclusion This study establishes biosimilarity of Lupin’s Pegfilgrastim
and Neulasta® with respect to PK and PD profiles. No
clinically meaningful differences were observed between the biosimilar
and the reference product in terms of immunogenicity, safety, and
tolerability profiles.