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12:00 AM
Nov 12, 2007
 |  BioCentury  |  Regulation

Biosimilar interferons in Europe

Biosimilar interferons in Europe

Product [company] Indication [date approved] Main efficacy studies [# pts] Study details
EMEA draft guideline Chronic HCV 1 trial in treatment-naïve pts Study design: non-inferiority trial comparing biosimilar against reference product over 48 weeks; if possible should be double-blind 1º endpoint: virologic response as measured by the proportion of patients with undetectable levels of HCV RNA at week 24; a 2 log decrease in viral load may be a co-primary endpoint
Intron A interferon alfa-2b (Alfatronol, Viraferon) [Schering-Plough] In combination w/ ribavirin for chronic HCV [3/9/00] C95-144, I95-145 [153, 192 pts, respectively, who relapsed after IFN treatment] Study design: double-blind trial comparing Intron...

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