In the generic drug business, most times it is best to be first!  This means trying to be first in development, submission, and (of course) approval.  But, in order to have a chance of being first, you must know what to do, and that is especially true of knowing what the bioequivalence (BE) requirements are.  Some first applicants take a flyer and may develop what they think may be appropriate to demonstrate BE and, while that may work, FDA, may ultimately have a different view.  For products for which no guidance is available, FDA is working overtime to get you that information based on a priority scheme (see previous post here).

So, for those of you looking ahead, the FDA published a list of “upcoming new and revised product-specific guidances (PSGs) to support the development and approval of safe and effective generic drug products, including the projected date of PSG publication, as a commitment under the Generic Drug User Fee Amendments of 2022 (GDUFA III).” This list will give prospective generic sponsors an idea of when they might see PSGs that would cement (to a certain extent) what was needed to establish bioequivalence of a generic product to its brand name counterpart.  The list can be found here and offers a crystal ball into when 72 new PSGs will issue (clearly the dates are approximate as is always the case with an FDA estimate of when something will happen).

In addition, the list provides insight into which current guidance documents are being looked at for a future revision and update.  There are 52 products on the revision list but, rest easy, as only three (3) are listed as major revisions. The three (3) major revisions are listed below with the reference product NDA as well as the proposed type of change and when the revision is likely to issue:

  • Gabapentin Oral Tablet NDA 022544 In Vivo Major Revision: Add an in vivo study 11/2023
  • Sotorosib Oral Tablet NDA 214665 In Vivo Major Revision: Change in study design for in vivo BE study(ies) 11/2023
  • Vandetanib Oral Tablet NDA 022405 In Vitro Major Revision: Add an in vitro study(ies) 02/2024

Major revisions are the most difficult to deal with, as this typically means additional or repeat studies will be required for anyone that has either completed BE work or has submitted an ANDA with BE that may no longer represent the FDA’s current thinking. The others on this list are reported as minor revisions, many of which are for the purposes of clarity, spelling errors, or (in some cases) down regulation from in vivo studies to include an in vitro study option. This is all great information for industry in regard to making plans for future products as well as keeping an eye on what changes may be coming down the pike that will likely require additional resources.