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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Detalles Bibliográficos
Autores principales: 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: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2018
Materias:
Original Articles
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5817835/
https://www.ncbi.nlm.nih.gov/pubmed/29417761
http://dx.doi.org/10.1002/prp2.380

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