Bioequivalence and Bioavailability Forum • WHO: Chapeau!

WHO: Chapeau! [BE/BA News]

posted by nobody – 2017-06-13 11:28 (2502 d 20:57 ago) – Posting: # 17492
Views: 9,785

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

Hi!

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

Complete thread:

WHO: scaling for AUC? Ohlbe 2017-06-12 13:29
- WHO: Chapeau! Helmut 2017-06-12 23:31
  - WHO: Chapeau! ElMaestro 2017-06-13 00:08
    - WHO: Chapeau!nobody 2017-06-13 09:28
    - WHO: Chapeau! Helmut 2019-06-10 11:23
      - WHO: Chapeau! ElMaestro 2019-06-11 18:51
- WHO: scaling for AUC confirmed Ohlbe 2021-07-02 10:31
  - No comparison of variabilities any more? Helmut 2021-07-02 15:11
  - WHO: scaling for AUC confirmed kratos 2021-08-03 10:38
    - EMA: scaling for AUC = utopia Helmut 2021-08-03 12:54