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A ‘Global Reference’ Comparator for Biosimilar Development
Major drug regulators have indicated in guidance their flexibility to accept some development data for biosimilars generated with reference product versions licensed outside their own jurisdictions, but most authorities require new bridging studies between these versions and the versions of them lic...
| Autores principales: | , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
Springer International Publishing
2017
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| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5541093/ https://www.ncbi.nlm.nih.gov/pubmed/28526943 http://dx.doi.org/10.1007/s40259-017-0227-4 |