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A phase III, randomised, double‐blind, multi‐national clinical trial comparing SB12 (proposed eculizumab biosimilar) and reference eculizumab in patients with paroxysmal nocturnal haemoglobinuria

Treatment of paroxysmal nocturnal haemoglobinuria (PNH) includes the monoclonal antibody eculizumab. This randomised, double‐blind, multi‐national cross‐over Phase III study in PNH patients aimed to demonstrate the equivalence of the proposed eculizumab biosimilar SB12 and reference eculizumab (Soli...

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Detalles Bibliográficos
Autores principales: Jang, Jun Ho, Gomez, Roberta Demichelis, Bumbea, Horia, Nogaieva, Larysa, Wong, Lily Lee Lee, Lim, Soo Min, Kim, Younsoo, Park, Jihye
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9928655/
https://www.ncbi.nlm.nih.gov/pubmed/36819188
http://dx.doi.org/10.1002/jha2.632