PF-06881893 (Nivestym™), a Filgrastim Biosimilar, Versus US-Licensed Filgrastim Reference Product (US-Neupogen®): Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Safety of Single or Multiple Subcutaneous Doses in Healthy Volunteers

Hsuan-Ming Yao,Faith D. Ottery,Troy Borema,Stuart Harris,Jeffrey Levy,Tom B. May,Shahrzad Moosavi,Jeffrey Zhang,Martin Summers

PF-06881893 (Nivestym™), a Filgrastim Biosimilar, Versus US-Licensed Filgrastim Reference Product (US-Neupogen®): Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Safety of Single or Multiple Subcutaneous Doses in Healthy Volunteers

2019

Hsuan-Ming Yao
Faith D. Ottery
Troy Borema
Stuart Harris
Jeffrey Levy
Tom B. May
Shahrzad Moosavi
Jeffrey Zhang
Martin Summers

Background Three comparative clinical studies assessed the pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity and safety of PF-06881893 (filgrastim-aafi; Nivestym™), a filgrastim biosimilar, versus US-licensed reference product (filgrastim; US-Neupogen®) in healthy volunteers (HVs).

Keywords:

Filgrastim
Pharmacology
Immunogenicity
Medicine
Biosimilar
Pharmacodynamics
Pharmacokinetics
Clinical endpoint
Absolute neutrophil count
Gastroenterology
Immunogenicity Study
Internal medicine

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