Similar Pharmacokinetics of the Adalimumab (Humira(®)) Biosimilar BI 695501 Whether Administered via Subcutaneous Autoinjector or Prefilled Syringe (VOLTAIRE(®)-AI and VOLTAIRE(®)-TAI): Phase 1, Randomized, Open-Label, Parallel-Group Trials

INTRODUCTION: BI 695501 has shown similar efficacy, safety, and immunogenicity to the adalimumab reference product, Humira(®). We present two phase 1 studies comparing the pharmacokinetics, safety, and immunogenicity of BI 695501 delivered via autoinjector (AI) vs. prefilled syringe (PFS). METHODS:...

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Detalles Bibliográficos
Autores principales: Ramael, Steven, Van Hoorick, Benjamin, Tiessen, Renger, van Iersel, Thijs, Moschetti, Viktoria, Lang, Benjamin, Sonderegger, Ivo, Wiebe, Sabrina, Liedert, Bernd, Jayadeva, Girish
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2018
Materias:
Original Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6251849/
https://www.ncbi.nlm.nih.gov/pubmed/29959660
http://dx.doi.org/10.1007/s40744-018-0119-1

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