Jan 12, 2015

Inching Closer to the First Biosimilar Approval in the U.S.

Last week we saw some significant biosimilar activity in the U.S. Specifically, on January 7, 2015, a U.S. Food and Drug Administration (FDA) Advisory Committee (Advisory Committee) voted 14-0 to approve Sandoz Inc.'s (Sandoz) filgrastim biosimilar (referred to as "EP2006") for all five indications of Neupogen® (the reference product manufactured by Amgen Inc. (Amgen)). Specifically, […]
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