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Waiving in vivo studies for monoclonal antibody biosimilar development: National and global challenges
Biosimilars are biological medicinal products that contain a version of the active substance of an already authorised original biological medicinal product (the innovator or reference product). The first approved biosimilar medicines were small proteins, and more recently biosimilar versions of inno...
| Autores principales: | , , , , , , , , , , , , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
Taylor & Francis
2016
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4966840/ https://www.ncbi.nlm.nih.gov/pubmed/26854177 http://dx.doi.org/10.1080/19420862.2016.1145331 |