FDA experts wave through Pfizer's copycat of an anemia med from Amgen, J&J, but a legal challenge still remains
Pfizer had no problem convincing an expert panel at the FDA that its biosimilar of Amgen’s blockbuster anemia med Epogen and Procrit, marketed by J&J, should get a quick green light for marketing.
The experts lined up 14 to 1 in favor of the approval, no big surprise given the agency’s clear endorsement in its written review from agency insiders. Their bottom line:
The totality of analytical data support the determination that “Epoetin Hospira” is highly similar to US-licensed Epogen/Procrit notwithstanding minor differences in clinically inactive components.
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