GP2015, a proposed etanercept biosimilar: Pharmacokinetic similarity to its reference product and comparison of its autoinjector device with prefilled syringes

British Journal of Clinical Pharmacology

Volumn 83, Issue 4, 2017, Pages 732-741

  von Richter, Oliver ^a   Skerjanec, Andrej ^b   Afonso, Miguel ^a   Sanguino Heinrich, Sabine ^a   Poetzl, Johann ^a   Woehling, Heike ^a   Velinova, Maria ^c   Koch, Annelize ^d   Kollins, Dmitrij ^a   Macke, Lars ^a   Wuerth, Guido ^a  

^a Sandoz Biopharmaceuticals   (Germany)

^b Sandoz Pharma Ltd   (Switzerland)

^c PRA HEALTH SCIENCES   (United States)

^d NORTHWICK PARK HOSPITAL   (United Kingdom)

Author keywords

autoinjector; bioequivalence; biosimilar; etanercept; GP2015; pharmacokinetics; subcutaneous administration

Indexed keywords

BIOSIMILAR AGENT; ETANERCEPT; GP 2015; NEUTRALIZING ANTIBODY; UNCLASSIFIED DRUG; IMMUNOSUPPRESSIVE AGENT;

ADULT; ANTIBODY TITER; AREA UNDER THE CURVE; ARTICLE; AUTOINJECTOR; BIOEQUIVALENCE; CONTROLLED STUDY; CROSSOVER PROCEDURE; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG DOSAGE FORM COMPARISON; DRUG FATALITY; DRUG SAFETY; DRUG TOLERABILITY; ELIMINATION HALF-LIFE; ELIMINATION RATE CONSTANT; FOLLOW UP; HEADACHE; HUMAN; HUMAN EXPERIMENT; IMMUNOGENICITY; INJECTION SITE REACTION; INTERMETHOD COMPARISON; MALE; MAXIMUM PLASMA CONCENTRATION; NEUTROPENIA; NORMAL HUMAN; OPEN STUDY; PHASE 1 CLINICAL TRIAL; PLASMA CONCENTRATION-TIME CURVE; PREFILLED SYRINGE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHINITIS; RHINOPHARYNGITIS; SYRINGE; ADOLESCENT; CLINICAL TRIAL; COMPARATIVE STUDY; MIDDLE AGED; SUBCUTANEOUS DRUG ADMINISTRATION; THERAPEUTIC EQUIVALENCE; YOUNG ADULT;

ADOLESCENT; ADULT; AREA UNDER CURVE; BIOSIMILAR PHARMACEUTICALS; CROSS-OVER STUDIES; DOUBLE-BLIND METHOD; ETANERCEPT; FOLLOW-UP STUDIES; HUMANS; IMMUNOSUPPRESSIVE AGENTS; INJECTIONS, SUBCUTANEOUS; MALE; MIDDLE AGED; SYRINGES; THERAPEUTIC EQUIVALENCY; YOUNG ADULT;

EID: 85006986159     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/bcp.13170     Document Type: Article

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