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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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Dettagli Bibliografici
Autore principale: Ventola, C. Lee
Natura: Artigo
Lingua:Inglês
Pubblicazione: MediMedia USA, Inc. 2013
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Accesso online:https://ncbi.nlm.nih.gov/pmc/articles/PMC3737980/
https://ncbi.nlm.nih.gov/pubmed/23946620
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