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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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Wedi'i Gadw mewn:
Manylion Llyfryddiaeth
Cyhoeddwyd yn:Diabetes Technol Ther
Prif Awduron: Heinemann, Lutz, Khatami, Hootan, McKinnon, Ross, Home, Philip
Fformat: Artigo
Iaith:Inglês
Cyhoeddwyd: Mary Ann Liebert, Inc. 2015
Pynciau:
Mynediad Ar-lein: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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