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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...
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| Publicado no: | Diabetes Technol Ther |
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| Main Authors: | , , , |
| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
Mary Ann Liebert, Inc.
2015
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| Assuntos: | |
| Acesso em linha: | https://ncbi.nlm.nih.gov/pmc/articles/PMC4504437/ https://ncbi.nlm.nih.gov/pubmed/25789689 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1089/dia.2014.0362 |
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