Pfizer Gets Green Light From the FDA on Epogen® Biosimilar

It has taken a long time, but Pfizer finally earned approval from the U.S. Food and Drug Administration (FDA) on the first biosimilar version of Epogen®. The drug, Retacrit® (epoetin alfa-epbx), had originally been submitted for approval in December 2014. Its much stalled road to approval is finally at an end. After an initial rejection, … Continue reading Pfizer Gets Green Light From the FDA on Epogen® Biosimilar →

Analyzing FDA Chief Gottlieb’s Remarks: One Challenge With no Easy Solution

Food and Drug Administration Commissioner Scott Gottlieb, MD, undoubtedly understands the threat to a successful biosimilar industry in the US, and his well-reported remarks emphasize some of the key issues. The policies that the FDA Commissioner wants to bring to bear on the multifaceted problem may be harder to implement. In this post, we examine … Continue reading Analyzing FDA Chief Gottlieb’s Remarks: One Challenge With no Easy Solution →