Bioequivalence and Bioavailability Forum

Hi Elzbieta!
You can find the RLD/RS (reference standard which can be used for BE study) information for USFDA from Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
Regards,
Dshah

Hi Elżbieta,

❝ It is my first question on the forum :).

Welcome!

❝ I would like to know where I can find information - list of reference drug and generic drug in order to eliminate opportunity to exchange generic to generic in pharmacoteraphy instead reference on generic.

Unlike in the U.S. (as dshah wrote above), there is no ‘reference drug’ in the European Economic Area). Any local reference could be used in a generic application and will be accepted in a decentralised procedure. Hence, it is possible: Generic manufactured in Germany, reference product from France, study performed in India, generic approved in Poland. These are the rules of the game. Only if a generic company ops for the centralised procedure (directly at the EMA), the product will be automatically approved in all members states.

If you are concerned about switching from one generic to another: Average bioequivalence (ABE) is not designed to answer this question. Individual bioequivalence (IBE) could, but was never implemnted in practice because the study sizes would be crazy (easily 4times higher than for ABE). However, we have empiric evidence for decades that switching between products showed no problems in terms of lacking efficacy (too low concentrations) or safety (AEs due too high concentrations).