Pharmacokinetics, pharmacodynamics, safety, and immunogenicity of Pelmeg(®), a pegfilgrastim biosimilar in healthy subjects.

A pharmacokinetics (PK)/pharmacodynamics (PD) study (EudraCT number 2015-002966-21) was conducted to investigate the biosimilarity of Pelmeg(®) (pegfilgrastim), a biosimilar to EU-authorized Neulasta(®), which is used in the clinic for prevention of chemotherapy-induced neutropenia. The single-dose, randomized, double-blind, two-way crossover study comprised 171 healthy male subjects, receiving Pelmeg and Neulasta (6 mg as subcutaneous injection) in a sequential manner. Primary PK endpoints were the area under the concentration curve from time zero to last measurable concentration (AUC(0-last)) and the maximum concentration (C(max)). The primary PD endpoint was the area under the effect curve (AUEC(0-last)) for absolute neutrophil count (ANC). Safety and immunogenicity were also assessed. Comparability was demonstrated for both PK endpoints, with geometric mean ratios (test/reference) for AUC(0-last) and C(max) of 95.2% and 92.8%, respectively. The corresponding confidence intervals (CIs; 94.3%) were [86.6%;104.7%] for AUC(0-last) and [84.4%;102.2%] for C(max), both being within the equivalence margin of 80.0% to 125.0%. Likewise, PD comparability was demonstrated, with the geometric mean ratio (test/reference) of AUEC(0-last) of 100.2%, with a corresponding CI (95%) of 98.7%-101.8%. No clinically meaningful differences were observed for safety and immunogenicity between Pelmeg and Neulasta. Pelmeg was found to be highly similar to the reference product.