Do the Outcomes of Clinical Efficacy Trials Matter in Regulatory Decision-Making for Biosimilars?

Kirsch-Stefan, N; Guillen, E; Ekman, N; Barry, S; Knippel, V; Killalea, S; Weise, M; Wolff-Holz, E

Kirsch-Stefan, N (通讯作者),Paul Ehrlich Inst, Fed Inst Vaccines & Biomed, Langen, Germany.

BIODRUGS, 2023; 37 (6): 855

Abstract

BackgroundThere is an increasing body of evidence supporting a more flexible approach in clinical data requirements for the approval of more complex b......

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