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 (AUC0‐last) and the maximum concentration (Cmax). The primary PD endpoint was the area under the effect curve (AUEC0‐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 AUC0‐last and Cmax of 95.2% and 92.8%, respectively. The corresponding confidence intervals (CIs; 94.3%) were [86.6%;104.7%] for AUC0‐last and [84.4%;102.2%] for Cmax, 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 AUEC0‐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.