HOLZKIRCHEN, Germany: Sandoz, a division of Novartis and the global leader in biosimilars, announced data demonstrating the pharmacokinetics (PK), pharmacodynamics (PD), safety and immunogenicity of proposed biosimilar pegfilgrastim as compared to the reference biologic, Neulasta®.
The Phase I study, conducted in healthy volunteers, confirmed that Sandoz biosimilar pegfilgrastim matches the reference biologic in terms of PK, PD, safety and immunogenicity profiles. The data were presented during the 2017 San Antonio Breast Cancer Symposium.
Sandoz biosimilar pegfilgrastim is currently under review by the European Medicines Agency (EMA) for use in the same indication as the reference biologic. Pegfilgrastim is a long-acting formulation of filgrastim (granulocyte colony-stimulating factor [G-CSF]).
About the study
Study participants were randomized to receive a single 6 mg subcutaneous injection of biosimilar pegfilgrastim or reference medicine on Day 0. After dosing, study participants underwent a 4-week assessment period followed by an 8-week washout period before crossing over to receive the other medicine and were assessed for a further 4-weeks.
The results demonstrated that Sandoz proposed biosimilar pegfilgrastim matched the reference medicine in the PK and PD comparisons as primary endpoints, in terms of absolute neutrophil count (the maximum effect attributed to study medication) (95% CI: [0.97, 1.02]) and maximum serum concentration of study medication after administration (90% CI: [1.03, 1.19]). Secondary endpoints of safety and immunogenicity were comparable between both groups.