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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

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