Bioequivalence and Bioavailability Forum

❝ If we were to go through well-established use route and if a BE study is required, what will be the comparator product? Only generics are available as the reference is not available globally.

Hi Tina,

That's one of the reasons I said it doesn't make sense. For old products the reference product may no longer on the market, having been withdrawn due to a plethora of generics. And by asking for a BE study it takes the term "well-established use" to the level of now being an oxymoron (ie. by definition, it can no longer be well-established if it needs a BE study). My advice, just don't get scientific advice from Denmark on this as nice and helpful as those folks tend to be.

❝ Though not applicable in my case, how do we find the global development of a product other than the MAH.

Maybe not global, but you have to show a European connection and sometimes it takes detective work to accomplish that. For example, we had to show that an Australian product was based on the same development as the European reference. In a convoluted way, we were able to find documentation that the European and New Zealand products were both manufactured in the same plant in Europe, and we were able to link the Australian product by way of showing that New Zealand distributed this particular drug to both its market and Australia. In addition, the quality people had some types of diffraction data that I don't understand, etc, etc, and microphotographs of the bead coating thickness, etc, etc. At the end of the day, EMA accepted that both came from the same development and we got a tap on the back from the guys upstairs.