Bioequivalence and Bioavailability Forum

Hi,

I agree with ElMaestro. If that's the case then you should discuss with your client to file a 10.3 (for me, FDA = 505(b)2). I don't understand why your sponsor wants generic in such a scenario since he already has clinical data supporting a product with a lower strength having similar efficacy of a higher strength (ok it wasn't done in EU so may not be useful).

(In USA) you can file a (b)2 by showing BE to the higher strength (i.e., 35 mg BE to 50 mg) and claiming equivalent efficacy ((b)2 without clinical). My old company did this before and I know a few others have done it too. It's a much better route than going generic (money wise in terms of profit).

But if you want to go through the BE route then I don't know how you can do it...

John