I had the good fortune to attend the FDLI Annual Meeting held on May 6th and 7th. The FDLI Annual Meeting is always a good conference where attendees are able to hear many great updates from the FDA and insights on issues related to our industry. This year was no exception, and the FDA had a robust contingent of both presenters and attendees.
Having spent my entire FDA career in the Office of Generic Drugs, naturally, I gravitated to a session titled “Do you copy? Biosimilars, Generics, Fast Tracks, and Fine Prints” to hear what it had to offer (it also helped that I either know or previously worked with most of the panelists). Martha Nguyen of the OGD’s Division of Policy Development (DPD) provided the OGD update, noting that the Generic Drug User Fee Act IV negotiations had ended, work on the GDUFA IV Commitment Letter is now ongoing, and minutes from all of the negotiation sessions were posted online and are available for review. Additionally, Martha noted that the OGD would be publishing a new Q1/Q2 guidance in early 2027 to describe the FDA’s interpretation and implementation of Section 6703, “Increasing Transparency in Generic Drugs Applications,” as well as other guidances of note including updates to 180-Day Exclusivity: Questions and Answers and 30-Month Stay of Approval of an ANDA or 505(b)(2) Application. A full list of the guidances under development can be found here: CDER Guidance Agenda (February 2026).
The Policy Director for the Office of Therapeutic Biologics and Biosimilars (OTBB), Mustafa Ünlü, then provided an overview of interchangeability for biosimilar products including the legal definition of interchangeability. During his presentation, Mustafa discussed the provenance of the FDA’s immunogenicity concerns when switching between biologic products that were related to use of epoetin products in the late twentieth century. Individuals who would like to learn more about this history can do so by reading an article titled “An unofficial legislative history of the Biologics Price Competition and Innovation Act 2009” (here). These immunogenicity concerns led to the FDA’s initially cautious approach requiring switching studies to establish interchangeability (but it was pointed out that the FDA’s position in relation to biosimilar insulins was much different and didn’t require clinical switching studies). As we all know, the FDA changed its position with respect to interchangeability studies in late 2025, but the history of how the FDA arrived at its decision and all of the steps that were taken was a fascinating recap of the history of the biosimilars program.
After these presentations, there was a discussion on other topics including the current legal landscape of labeling carve-outs and the upcoming Supreme Court decision Hikma v. Amarin. As part of this discussion, it was noted that because the case is a post‑launch case, its impact will likely be relegated to any future post-launch cases that will focus on marketing materials, information on websites, and other related information allegedly resulting in induced infringement. I’m certainly no expert on the details of the case but the discussion triggered a memory for me of when I first joined the FDA in 2000; there was a proposal that would have permitted ANDA sponsors to state on their labels that their products were therapeutically equivalent to the RLDs. From what I recall, it was determined that the proposal was not legal and that an ANDA sponsor could not state on their label either “Therapeutically Equivalent to Insert Proprietary Name” or “AB-rated to Insert Proprietary Name.” I believe that the underlying legal issue was use of the proprietary name for the RLD on the label of the ANDA product, but that may be a gross oversimplification of the legal issue. Perhaps it’s time to revisit such a proposal as inclusion of these types of statements on ANDA labels (which would be reviewed and approved by the FDA) might assist with some of the disputes in this case. Moreover, I would point out, as a previously practicing pharmacist, that these types of statements on labels would be extremely helpful with linking generic products to the corresponding RLDs for certain classes of drugs, in particular for oral contraceptives where the use of proprietary names for generics results in some challenges in linking the generic products to the RLDs. All this would take is a minor legislative change; after all, the FDA was recently successful in getting Q1/Q2 legislation passed. We can all hope.
