Taking Biosimilars Down A PEG: Why Copying Neulasta Isn’t So Easy
Executive Summary
Biosimilar sponsors are 0-3 so far in attempts to win US FDA approval for copies of Amgen’s pegfilgrastim (Neulasta). FDA’s recent review of a novel clotting factor formulation offers a clue why it is turning out to be harder than it seems to copy a pegylated protein.
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