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A critical review of the United States regulatory pathways for determining the equivalence of efficacy between CT-P13 and original infliximab (Remicade(®))
We evaluated the appropriateness of various equivalence margins for CT-P13, an infliximab biosimilar, in the PLANETRA clinical trial. The 95–95% method was used to independently determine an equivalence margin by pooling the historical clinical trials with original infliximab versus placebo, identif...
| Autores principales: | , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
Dove
2020
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7381822/ https://www.ncbi.nlm.nih.gov/pubmed/32764882 http://dx.doi.org/10.2147/DDDT.S254776 |