NDLI: Bioequivalence studies of omnitrope, the first biosimilar/rhGH follow-on protein: two comparative phase 1 randomized studies and population pharmacokinetic analysis.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Stanhope, Richard Sörgel, Fritz Gravel, Patricia Pannatier Schuetz, Yannic B. Zabransky, Markus Muenzberg, Michael
Description	Country affiliation: United kingdom Author Affiliation: Stanhope R ( Portland Hospital, London, United Kingdom.)
Abstract	This article discusses the bioequivalence of Omnitrope (Sandoz's rhGH biosimilar) and Genotropin (reference rhGH product), assessed in the first 2 clinical phase 1 studies conducted during the development of Omnitrope. Both of these phase 1 studies were randomized, double-blind, crossover studies, each involving 24 healthy volunteers who underwent pituitary somatrope cell down-regulation using octreotide. Three different formulations of recombinant human growth hormone (rhGH) were compared: Omnitrope lyophilisate, Omnitrope liquid and Genotropin (lyophilized powder for injection). Both pharmacokinetics (area under the curve [AUC], C(max), t(max) and t(1/2)) and pharmacodynamics (serum levels of insulin-like growth factor 1, insulin-like growth factor binding protein-3 and non-esterified fatty acid) were assessed after a single subcutaneous injection of 5 mg rhGH. The 3 formulations had comparable pharmacokinetics and pharmacodynamics. All the 90% confidence intervals of the ratios of the least squares means for the pharmacokinetic and pharmacodynamic parameters AUC and C(max) were within the predefined FDA and EMEA acceptance range of 80%-125% for bioequivalence. In addition, a comparative population pharmacokinetic analysis further supports that Omnitrope lyophilisate, Omnitrope liquid and Genotropin can be regarded as equivalent in terms of pharmacokinetics. Therefore, Omnitrope lyophilisate was demonstrated to be bioequivalent to both Genotropin and the Omnitrope liquid formulation.
File Format	HTM / HTML
ISSN	00912700
Issue Number	11
Volume Number	50
e-ISSN	15524604
Journal	The Journal of Clinical Pharmacology
Language	English
Publisher	Wiley
Publisher Date	2010-11-01
Publisher Place	Great Britain (UK)
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Pharmacology Human Growth Hormone Pharmacokinetics Recombinant Proteins Adolescent Adult Area Under Curve Cross-over Studies Double-blind Method Fatty Acids, Nonesterified Blood Female Freeze Drying Half-life Administration & Dosage Pharmacology Humans Injections, Subcutaneous Insulin-like Growth Factor Binding Protein 3 Insulin-like Growth Factor Binding Proteins Drug Effects Insulin-like Growth Factor I Metabolism Least-squares Analysis Male Middle Aged Therapeutic Equivalency Young Adult Clinical Trial, Phase I Comparative Study Journal Article Randomized Controlled Trial
Content Type	Text
Resource Type	Article
Subject	Pharmacology Pharmacology (medical)

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