Immunogenicity and safety of a proposed pegfilgrastim biosimilar MSB11455 versus the reference pegfilgrastim Neulasta^® in healthy subjects: A randomized, double-blind trial.

ABSTRACT: MSB11455 is a proposed biosimilar to the currently licensed reference pegfilgrastim (Neulasta^® ). This study was designed primarily to compare the immunogenicity of MSB11455 and Neulasta^® . As secondary objectives, the safety and tolerability of MSB11455 and Neulasta^® were also compared. Healthy adult subjects were randomized to either MSB11455 or Neulasta^® , stratified by antipolyethylene glycol (PEG) antibody status at screening and study site. Subjects received a single subcutaneous dose of MSB11455 or Neulasta^® (both 6 mg/0.6 mL) on day 1 of each of two study periods (same product in both periods), separated by a washout of 28-35 days. Immunogenicity samples were taken predose and up to day 84 post-first dose. Noninferiority was co

SUBMITTER: Wynne C 

PROVIDER: S-EPMC7183238 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature