Plant Problems Lead The FDA To Reject Pfizer's Epogen Biosimilar Again

Pfizer 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.