Pharmacokinetic equivalence, comparable safety, and immunogenicity of an adalimumab biosimilar product (M923) to Humira in healthy subjects

The aims of this randomized, double‐blind, three‐arm, single‐dose study were to demonstrate pharmacokinetic (PK) equivalence of the adalimumab biosimilar M923 (hereafter referred to as “M923”) to each of 2 reference products, and to assess M923's safety and immunogenicity. Primary PK endpoints...

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Detalhes bibliográficos
Publicado no:Pharmacol Res Perspect
Main Authors: Hillson, Jan, Mant, Tim, Rosano, Molly, Huntenburg, Carolyn, Alai‐Safar, Mehrshid, Darne, Siddhesh, Palmer, Donna, Pavlova, Borislava G., Doralt, Jennifer, Reeve, Russell, Goel, Niti, Weilert, Doris, Rhyne, Paul W., Chance, Kamali, Caminis, John, Roach, James, Ganguly, Tanmoy
Formato: Artigo
Idioma:Inglês
Publicado em: John Wiley and Sons Inc. 2018
Assuntos:
Original Articles
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC5817835/
https://ncbi.nlm.nih.gov/pubmed/29417761
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1002/prp2.380
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