Bioequivalence and Bioavailability Forum

Dear Ohlbe & Mikkabel,

without quoting from the previous posts: By definition generics have to be equivalent to the comparator, not better.

❝ Who can predict their reactions ?

❝ Impossible to say without any information on the molecule, and even with information I would not try my luck.

As per Directive 2001/83/EC, in a generic application (acc. to Art. 10(1)), assessors have no choice but not accepting it.
If a product is considered better than the comparator (e.g., less food effects, whatsoever), one may only opt for the hybrid route (acc. to Art. 10(3)). How much additional – clinical – data is required has to be discussed with the agency.

Important: Once the procedure has started, one cannot switch from to 10(1) to 10(3).