Pharmacokinetics and Pharmacodynamics of a Proposed Pegfilgrastim Biosimilar MSB11455 Versus the Reference Pegfilgrastim Neulasta in Healthy Subjects: A Randomized, Double-blind Trial

• Published in: Clinical therapeutics Vol. 42; no. 8; pp. 1508 - 1518.e1
• Main Authors: Lickliter, Jason, Kanceva, Radmila, Vincent, Emmanuelle, Schueler, Armin, Harrison-Moench, Eleanor, Yue, Corinne Seng, Stahl, Michael, Ullmann, Martin, Ghori, Vishal, Griffin, Paul
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.08.2020; Elsevier Limited
• Subjects: Adolescent; Adult; Area Under Curve; bioequivalence; Biological products; Biosimilar Pharmaceuticals - pharmacokinetics; Biosimilar Pharmaceuticals - pharmacology; biosimilarity; Blood; Bone marrow; Chemotherapy; Cross-Over Studies; Double-Blind Method; Double-blind studies; Drug dosages; Female; Filgrastim - pharmacokinetics; Filgrastim - pharmacology; Healthy Volunteers; Humans; Immunogenicity; Internal Medicine; Laboratories; Leukocyte Count; Male; Medical Education; Middle Aged; MSB11455; Neutropenia; Neutrophils; Neutrophils - drug effects; pegfilgrastim; Pharmacodynamics; Pharmacokinetics; Polyethylene Glycols - pharmacokinetics; Polyethylene Glycols - pharmacology; Safety; Sample size; Therapeutic Equivalency; Vital signs; Young Adult; United States > US; pharmacokinetics; MSB11455; pegfilgrastim; pharmacodynamics; bioequivalence; biosimilarity

MSB11455 is a proposed biosimilar to the reference pegfilgrastim (Neulasta®). This pivotal equivalence study (NCT03251248) assessed the pharmacokinetic and pharmacodynamic equivalence of MSB11455 to the reference product. This 2-way, 2-sequence, group-sequential, crossover study was conducted in hea...