Back to School: How biopharma can reboot drug development. Access exclusive analysis here

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

Read the full 583 word article

Trial Subscription

Get a two-week free trial subscription to BioCentury

SIGN UP

Article Purchase

This article may not be distributed to non-subscribers
More Info >PURCHASE