FDA’s Exploration of Innovation vs. Access Continues with Public Hearing on the Biosimilar Marketplace

Just like last year when it held a public hearing and rolled out the Generic Drug Action Plan, FDA is following its recent announcement of the Biosimilar Action Plan with a Public Hearing on competition in the biologics market entitled Facilitating Competition and Innovation in the Biological Products Marketplace.  This hearing seeks input from the public on how FDA can enhance efforts to increase access to the innovative treatment options in the biological products marketplace.  The Public Hearing will be held at FDA on September 4, 2018 from 9 a.m. to 5 p.m. and will involve presentations from public stakeholders rather than Agency officials or invitees.

FDA is looking for information and comments from a broad group of stakeholders (i.e. patients, researchers, healthcare providers, manufacturers, professional organizations, and the public) on how the Agency can best facilitate greater availability of biosimilar and interchangeable products while balancing competition and innovation. FDA is particularly looking for input on Agency goals enumerated in the Biosimilar Access Plan (explained here): facilitating efficient development of biosimilar and interchangeable products; developing information resources and tools to streamline development; enhancing efficiency of FDA review of biosimilar and interchangeable products; providing additional clarity about FDA’s regulation of biological products; increasing stakeholder understanding of biological products; and addressing attempts to “game” FDA requirements or otherwise delay market entry of competing biological products.

FDA also raises several questions about additional steps with respect to the regulation of biological products. These questions are on topics of interest to stakeholders of all types, such as biosimilar access to markets, use of the Purple Book, ensuring marketplace confidence, costs of studies required for approval, non-U.S.-licensed comparators, and product lifecycle incentives.

Not surprisingly given the subject matter, FDA’s questions seek to balance incentives for innovation with access to biosimilar and interchangeable products. FDA specifically asks what it can do to ensure an appropriate balance with respect to multiple licensed conditions of use.  Presumably, this is to address the concerns that have been raised by innovators for years about the fairness of carve-outs.

Interestingly, FDA raises questions about the potential application of “umbrella exclusivity” under the exclusivity provisions for reference products section 351(k)(7) of the Public Health Service Act. Previously addressed in the 1989 Proposed Rule implementing ANDA regulations, umbrella exclusivity attaches to all versions of the active moiety or innovative change entitled to such exclusivity rather than only the specific drug product that received approval. Approval of a new dosage form or other types of changes does not destroy exclusivity.  FDA ultimately decided to adopt this interpretation of exclusivity under the Hatch Waxman Amendments and is now considering whether it would help shield certain biologics that are not otherwise eligible for exclusivity under section 351(k)(7)(c).  FDA is hoping to hear arguments in favor and against umbrella exclusivity with a robust discussion of its impact on innovation and market entry.

The Public Hearing will be held at FDA’s White Oak location. Those interested in attending or presenting at the hearing should register by sending an email to OMPTfeedback@fda.hhs.gov by August 14, 2018. Requests for participation in the open public hearing will be accepted until 9 a.m. on Tuesday, September 4, 2018.