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Is Extrapolation of the Safety and Efficacy Data in One Indication to Another Appropriate for Biosimilars?
CT-P13, the world’s first biosimilar monoclonal antibody to infliximab, was approved for marketing in South Korea for all the six indications of infliximab, which Europe may follow, although the product was tested only in rheumatoid arthritis (RA) with a limited pharmacokinetic comparison in ankylos...
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| Auteur principal: | |
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| Format: | Artigo |
| Langue: | Inglês |
| Publié: |
Springer US
2013
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| Sujets: | |
| Accès en ligne: | https://ncbi.nlm.nih.gov/pmc/articles/PMC3889539/ https://ncbi.nlm.nih.gov/pubmed/24114449 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12248-013-9534-y |
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