WHO: Chapeau! [BE/BA News]

posted by nobody – 2017-06-13 09:28 (1890 d 05:02 ago) – Posting: # 17492
Views: 8,639

» It of course comes at a handy time when WHO are opening up for biologics. This isn't a co-incidence :-D:-D:-D.


Didn't have a look at PARs, but EMA has a high number of biosimilars approved (compared to e.g. FDA), is the variability in AUC really an issue and how did the applicants account for, if EMA allows no scaling for AUC?

Just asking... :-)

Kindest regards, nobody

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