Biological Characterization of SB3, a Trastuzumab Biosimilar, and the Influence of Changes in Reference Product Characteristics on the Similarity Assessment

BACKGROUND: SB3 has been developed as a trastuzumab biosimilar, a therapeutic monoclonal antibody targeted to human epidermal growth factor receptor 2 (HER2), and approved by the European Commission and United States (US) Food and Drug Administration (FDA). During the developmental period of a biosi...

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Detalles Bibliográficos
Autores principales: Lee, Jae Hee, Paek, Kyungyeol, Moon, Jae Hyon, Ham, Sunyoung, Song, Jinsu, Kim, Seokkyun
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2019
Materias:
Original Research Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6647423/
https://www.ncbi.nlm.nih.gov/pubmed/31190280
http://dx.doi.org/10.1007/s40259-019-00362-5

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6647423/
https://www.ncbi.nlm.nih.gov/pubmed/31190280
http://dx.doi.org/10.1007/s40259-019-00362-5

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