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Oct 22, 2007
 |  BioCentury  |  Regulation

ESAs then & now

ESAs then & now

ESAs then & now
EMEA's documentation for its approval of a biosimilar epoetin alfa from Novartis' Sandoz subsidiary provides the first look into the dataset that supported approval. Sandoz skipped Phase II dose-ranging trials and conducted a Phase III program in chronic renal failure patients on dialysis that had about 25% fewer patients than the number Amgen studied in four key clinical trials to gain its original FDA approval of Epogen for the indication. The gap between the size of major efficacy trials of the biosimilar and those conducted for more recent approvals of second-generation innovator drugs Aranesp darbepoetin alfa and Mircera epoetin beta, as well as the recently started Phase III...

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