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Batch-to-Batch Consistency of SB4 and SB2, Etanercept and Infliximab Biosimilars
BACKGROUND: Biosimilars must meet stringent regulatory requirements, both at the time of authorization and during their lifecycle. Yet it has been suggested that divergence in quality attributes over time may lead to clinically meaningful differences between two versions of a biologic. Therefore, th...
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| Publicado no: | BioDrugs |
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| Main Authors: | , , , , , , , , , , |
| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
Springer International Publishing
2020
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| Assuntos: | |
| Acesso em linha: | https://ncbi.nlm.nih.gov/pmc/articles/PMC7113226/ https://ncbi.nlm.nih.gov/pubmed/31925703 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1007/s40259-019-00402-0 |
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