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FDA adopts European approach to biosimilars

Eileen McDermott, New York


The Food and Drug Administration has shed some light on its approach to assessing biosimilars in a recent article published in the New England Journal of Medicine

The agency said it will take a so-called totality of the evidence approach to making regulatory decisions on biologic drugs. This approach was influenced in part by the European Medicines Agency (EMA), which approved its first biologic drug in 2006.


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