you would be correct in your assumption. If the route or PK/PD...

you would be correct in your assumption. If the route or PK/PD changes then new trial would be required. Example below : )

source: https://www.fda.gov/media/72246/download

So will a change it tablet to la nanosuspension require a trial?

source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4865745/


Yes, it is theoretically possible albeit often a long shot to reformulated without needing to recommence the trials.


Source: https://www.biosimilardevelopment.com/doc/the-impact-of-reformulation-strategies-on-pharmaceuticals-biologics-0001







Yes it is an issue but seems like it’s known and being managed. Approval can still happen with current formulation. Reformulated to liquid formulation and reset patent clock and exclusivity.

Downside is it can delay trials as I have learnt from RAC, so patience may be required.