The role of analytical science in the debate over biosimilars

The role of analytical science in the debate over biosimilars

Currently, there is no regulatory pathway for generic versions of biopharmaceutical drugs in the US market. However, history shows FDA has embraced biopharmaceutical policy change guided or even driven by new analytical techniques, in 1996, FDA promulgated the concept of the well-characterized biolo...

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Veröffentlicht in:Pharmaceutical technology Europe 2008-04, Vol.20 (4), p.90
1. Verfasser: Mazzeo, Jeffrey R
Format: Artikel
Sprache:eng
Schlagworte:
Biological products
Biotechnology
Clinical trials
Comparative analysis
Debates
Generic drugs
Intellectual property
Manufacturing
Pharmaceutical industry
Proteins
Science
Scientific imaging
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Zusammenfassung:Currently, there is no regulatory pathway for generic versions of biopharmaceutical drugs in the US market. However, history shows FDA has embraced biopharmaceutical policy change guided or even driven by new analytical techniques, in 1996, FDA promulgated the concept of the well-characterized biologic product (WCBP), which acknowledged that analytical techniques could definitively determine a biologic product's identity, purity, potency and stability.
ISSN:1753-7967