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The ‘totality-of-the-evidence’ approach in the development of PF-06438179/GP1111, an infliximab biosimilar, and in support of its use in all indications of the reference product
The ‘totality-of-the-evidence’ biosimilarity concept requires that sufficient structural, functional, nonclinical, and clinical data are acquired in a stepwise manner, to demonstrate that no clinically meaningful differences in quality, safety, or efficacy are observed compared with the reference pr...
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| Pubblicato in: | Therap Adv Gastroenterol |
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| Autori principali: | , , , , , , |
| Natura: | Artigo |
| Lingua: | Inglês |
| Pubblicazione: |
SAGE Publications
2019
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| Soggetti: | |
| Accesso online: | https://ncbi.nlm.nih.gov/pmc/articles/PMC6566480/ https://ncbi.nlm.nih.gov/pubmed/31223341 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1177/1756284819852535 |
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