In the newest posting of bioequivalence (BE) guidance documents (here), the Office of Generic Drugs has issued 35 new guidance documents and revised 22 previously issued guidances.
We have previously posted about the impact of revised BE guidances and now there are 22 more that firms must review to see if any of the changes recommended will mean more work or repeat studies. For those that might have approved applications, the question of whether new BE studies will be required to permit continued marketing will be need to be answered.
I have harped on the point that one wish I have is that OGD would begin to list what the changes are when a revision is made to a BE recommendation, much like industry does in a revision section of an SOP. That would make understanding the revisions much easier for industry. Let’s hope they do this at some point.
One of the revisions that stood out in my mind is the one for Morphine Sulfate Extended-Release Capsules, where OGD is now requiring 6 in vivo studies for the demonstration of BE across all strengths. Now there is a hefty BE bill!
