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Assessing Analytical and Functional Similarity of Proposed Amgen Biosimilar ABP 980 to Trastuzumab

BACKGROUND: ABP 980 has been developed as a biosimilar to Herceptin(®) (trastuzumab). Comprehensive analytical characterization incorporating orthogonal analytical techniques was used to compare ABP 980 to trastuzumab reference products sourced from the United States (US) and the European Union (EU)...

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Detalles Bibliográficos
Autores principales: Hutterer, Katariina M., Polozova, Alla, Kuhns, Scott, McBride, Helen J., Cao, Xingxiang, Liu, Jennifer
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6533217/
https://www.ncbi.nlm.nih.gov/pubmed/30972630
http://dx.doi.org/10.1007/s40259-019-00350-9