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Biosimilars: Key regulatory considerations and similarity assessment tools
A biosimilar drug is defined in the US Food and Drug Administration (FDA) guidance document as a biopharmaceutical that is highly similar to an already licensed biologic product (referred to as the reference product) notwithstanding minor differences in clinically inactive components and for which t...
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| Publicado no: | Biotechnol Bioeng |
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| Main Authors: | , , , , , |
| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
John Wiley and Sons Inc.
2017
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| Assuntos: | |
| Acesso em linha: | https://ncbi.nlm.nih.gov/pmc/articles/PMC5698755/ https://ncbi.nlm.nih.gov/pubmed/28842986 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1002/bit.26438 |
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