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Biosimilars: Part 1: Proposed Regulatory Criteria for FDA Approval

Biosimilars, although not identical to their originator product, are expected to become essential in reducing health care costs and improving access to lifesaving drugs. The FDA must find a way to balance rigorous testing to ensure quality, as is done for generic chemical drugs, with providing a cos...

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Bibliografske podrobnosti
Glavni avtor: Ventola, C. Lee
Format: Artigo
Jezik:Inglês
Izdano: MediMedia USA, Inc. 2013
Teme:
Online dostop:https://ncbi.nlm.nih.gov/pmc/articles/PMC3737980/
https://ncbi.nlm.nih.gov/pubmed/23946620
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