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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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Bibliografiske detaljer
Udgivet i:Diabetes Technol Ther
Main Authors: Heinemann, Lutz, Khatami, Hootan, McKinnon, Ross, Home, Philip
Format: Artigo
Sprog:Inglês
Udgivet: Mary Ann Liebert, Inc. 2015
Fag:
Online adgang: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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