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Drug Development and Potential Regulatory Paths for Insulin Biosimilars

Under the Biologics Price Competition and Innovation Act (BPCI Act), a biological product may be demonstrated to be “biosimilar” if data show that, among other things, the product is “highly similar” to an already-approved biological product. Biosimilar insulins have the potential to reduce ever gro...

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Shranjeno v:
Bibliografske podrobnosti
izdano v:J Diabetes Sci Technol
Main Authors: Minocha, Mukul, Gobburu, Jogarao
Format: Artigo
Jezik:Inglês
Izdano: SAGE Publications 2014
Teme:
Online dostop:https://ncbi.nlm.nih.gov/pmc/articles/PMC4454099/
https://ncbi.nlm.nih.gov/pubmed/24876531
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1177/1932296813516954
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