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The road from development to approval: evaluating the body of evidence to confirm biosimilarity
Biosimilars are products that contain a similar version of the active substance of an already authorized original biologic medicinal product (reference medicinal product). Their development requires special consideration, as similarity to the reference agent needs to be established through a compreh...
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| Publicado no: | Rheumatology (Oxford) |
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| Main Authors: | , |
| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
Oxford University Press
2017
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| Assuntos: | |
| Acesso em linha: | https://ncbi.nlm.nih.gov/pmc/articles/PMC5850836/ https://ncbi.nlm.nih.gov/pubmed/28903545 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1093/rheumatology/kex279 |
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