Pfizer grabs a solid endorsement from FDA insiders for their knockoff of Amgen’s flagship drug Epogen
Pfizer’s second attempt to win an FDA OK for Hospira’s biosimilar of Amgen’s fast-declining anemia drug, Epogen, is on course to a likely approval — with few or no fireworks planned for an upcoming panel review.
Rejected by the FDA back in the early biosimilar days of 2015, regulators started off their review by giving a clear nod to the second effort, which comes after the pharma giant acquired Hospira and its pipeline of knockoffs for $16 billion.
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