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Regulatory Considerations for Biosimilars
Currently there is considerable interest in the legislative debate around generic biological drugs or “biosimilars” in the EU and US due to the large, lucrative market that it offers to the industry. While some countries have issued a few regulatory guidelines as well as product specific requirement...
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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Medknow Publications
2010
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| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3149401/ https://www.ncbi.nlm.nih.gov/pubmed/21829775 |