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Clinical Evaluation of Humira(®) Biosimilar ONS-3010 in Healthy Volunteers: Focus on Pharmacokinetics and Pharmacodynamics

ONS-3010 is being developed by Oncobiologics Inc. (Cranbury, NJ, USA) as a biosimilar of Humira(®). This randomized, double blind, single-center phase I study (EudraCT registration # 2013-003551-38) was performed to demonstrate pharmacokinetic (PK) biosimilarity between two reference products (Humir...

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Detalhes bibliográficos
Publicado no:Front Immunol
Main Authors: Dillingh, Marlous R., Reijers, Joannes A. A., Malone, Karen E., Burggraaf, Jacobus, Bahrt, Kenneth, Yamashita, Liz, Rehrig, Claudia, Moerland, Matthijs
Formato: Artigo
Idioma:Inglês
Publicado em: Frontiers Media S.A. 2016
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC5124695/
https://ncbi.nlm.nih.gov/pubmed/27965661
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.3389/fimmu.2016.00508
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