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Biosimilar Pegfilgrastim-cbqv Demonstrated Similar Immunogenicity to Pegfilgrastim in Healthy Subjects Across Three Randomized Clinical Studies

INTRODUCTION: Biologic therapeutics can trigger immune responses in patients. As part of the totality of evidence that is required for regulatory approval of biosimilars, immunogenicity similarity must be assessed in the clinical programs. Pegfilgrastim-cbqv (UDENYCA(®)) is a pegfilgrastim biosimila...

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Detalles Bibliográficos
Autores principales: Civoli, Francesca, Finck, Barbara, Tang, Helen, Hodge, Jennifer, O’Kelly, Hillary, Vexler, Vladimir
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8918144/
https://www.ncbi.nlm.nih.gov/pubmed/35034311
http://dx.doi.org/10.1007/s12325-021-02024-x