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An Overview of Current Regulatory Requirements for Approval of Biosimilar Insulins
Insulin analog patent expiry is likely to mean that, increasingly, copies of original biopharmaceutical products will be submitted for authorization. Experience with biosimilars in other therapeutic areas suggests that careful regulation and caution are needed. Published guidelines of regulatory aut...
| Autores principales: | , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
Mary Ann Liebert, Inc.
2015
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4504437/ https://www.ncbi.nlm.nih.gov/pubmed/25789689 http://dx.doi.org/10.1089/dia.2014.0362 |