The closest thing to a shoo-in Pfizer has ever handed to the FDA just got rejected
Pfizer $PFE had just about everything going for it when the regulators at the FDA undertook the final review of its biosimilar of Amgen’s blockbuster anemia med Epogen/Procrit. The in-house review at the agency bluntly said it was the same drug. All but one member of the FDA panel that reviewed it said it should get a green light. And then the Supreme Court axed Amgen’s legal challenge $AMGN on the 180-day notice rule, seemingly leaving the road to the drug market wide open.
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