Debate over details of US biosimilar pathway continues to rage

Although FDA officials mapped out a draft guidance for biosimilar products early this year, opinions over what regulatory standards should be adopted remain sharply divided. Biosimilar manufacturers, innovator companies and other stakeholders aired their views during a public hearing, convened May 1...

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Bibliographic Details
Published in:Nature biotechnology 2012-07, Vol.30 (7), p.577-577
Main Author: Fox, Jeffrey L
Format: Article
Language:English
Subjects:
631/61/51
706/703
Agriculture
Bioinformatics
Biological products
Biomedical and Life Sciences
Biomedical Engineering/Biotechnology
Biomedicine
Biosimilar Pharmaceuticals - therapeutic use
Biotechnology
Biotechnology industry
Clinical Trials as Topic
Drug Industry - economics
Generic drugs
Guidelines
Health aspects
Humans
Laws, regulations and rules
Life Sciences
news
Pharmaceutical industry
United States
United States Food and Drug Administration - economics
United States Food and Drug Administration - legislation & jurisprudence
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Description
Summary:Although FDA officials mapped out a draft guidance for biosimilar products early this year, opinions over what regulatory standards should be adopted remain sharply divided. Biosimilar manufacturers, innovator companies and other stakeholders aired their views during a public hearing, convened May 11 at the FDA White Oak Campus in Silver Spring MD.
ISSN:1087-0156
1546-1696
DOI:10.1038/nbt0712-577