Do low- to middle-income countries need a biosimilar approval pathway based on a full comparability exercise?
Journal Title: Generics and Biosimilars Initiative Journal - Year 2013, Vol 2, Issue 4
Abstract
Despite the fact that hepatitis C is a disease of global importance, many countries cannot afford the costly but effective combination treatment of peg-interferon and ribavirin, which was recently included in the World Health Organization Essential Medicines List. Given that peg-interferon is a biotechnological product, should low- to middle-income countries adopt the burdensome biosimilar approval pathway of western countries or should they find a more pragmatic approach, focusing on efficacy and safety to gain access to affordable biotechnological products?
Authors and Affiliations
Armando A Genazzani, Nicola Magrini
Keywords
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- EP ID EP354628
- DOI 10.5639/gabij.2013.0204.044
- Views 111
- Downloads 0
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