A pre-publication Federal Register notice today (here) announced the first group of product-specific guidances (PSGs) for which the requirement for a fed, in-vivo bioequivalence (BE) study has been removed. In some instances, the fasting, in vivo bioequivalence requirements were modified such that now only one in vivo study will be required to support a bioequivalence determination. This move comes as the ICH M13A BE Guideline will become final tomorrow as well (see here). We have posted about this seismic change previously here, here, and here.
While the reduction in development costs will undoubtedly help generic applicants, contract research organizations (CROs) will find that about half of their business from BE studies for generics will be lost. That begs the question as to whether CROs will begin raising their prices for the single studies to help make up the difference in lost revenue. Time will tell.
There are a number of other unanswered questions that exist regarding the implementation of M13A. For example, what do you do if you performed a fed study and it failed, when can you begin submitting ANDAs with just a single study without getting a refuse-to-receive letter, and is it permissible to stop a fed study that is in progress if the requirement for the fed study has been eliminated? There are numerous other scenarios that can be conjured up but, as noted in a previous blog post cited at the beginning of this post, the FDA will hold a public meeting on November 21st to discuss M13A and the ramifications of it dropping fed-study requirements as well as other provisions within the newly adopted guidance.
