Hello from sunny Orlando and the AAM annual meeting!  The FDA’s Jacqueline Corrigan-Curay, Principal Deputy Director, CDER, FDA, had the honor of providing the FDA’s keynote address.  She started her talk by highlighting some of the accomplishments of GDUFA II, such as calling out the 490 first-generic approvals and 553 complex-generic approvals out of a total of 4,782 ANDAs approved or tentatively approved during the program.  The success of biosimilars was measured in terms of cumulative progress from the first biosimilar approval in 2015 of Zarxio (filgrastim-sndz) to the end of 2022, where we now have forty approved biosimilars with three having achieved the interchangeable designation.  The good news for industry on interchangeable products is that those three provided three different sets of data to support interchangeability.  That’s indicative that the FDA is taking a product-specific approach rather than setting blanket requirements.  A switching study is not always required, nor is immunogenicity data always required.  There is room to work together.

Looking to the future, Dr. Corrigan-Curay highlighted some of the features of GDUFA III and BsUFA III.  For generic drugs, there will be more emphasis on first-cycle approvals and reducing the number of overall cycles, in addition to setting goals around responses to suitability petitions.  For biosimilars, new supplement categories and timelines were added to support faster reviews.  There was an update to meeting management as well to align the program more closely with PDUFA by including a new follow-up opportunity for sponsors to submit clarifying questions after meetings to ensure that the sponsor and the FDA are on the same page.

Dr. Corrigan-Curay called attention to the GDUFA III Science and Research Priority Initiatives for 2023 and noted that BsUFA is joining the party with its own regulatory science program being added with this iteration of the biosimilar user fee program.  The research roadmap for biosimilars was released on January 25th with comments due to the docket by April 5, 2023.  Be sure to add your comments here and contribute to the conversation by April 5th.

She also took some time to emphasize the National Strategy for a Resilient Public Health Supply Chain.  The FDA has focused on supply-chain surveillance and is working to communicate that resiliency requires quality manufacturing, also known as Quality Management Maturity, or QMM.  QMM will optimize a manufacturer’s ability to detect and react to variabilities in their products, and a proactive stance may help companies to react more quickly.  The FDA is encouraging and incentivizing the use of QMM rather than mandating its use, and supporting advanced manufacturing (AM) through the continuation of the Emerging Technology Program,  To dispel some common myths, Dr. Corrigan-Curay confirmed that applications that used AM techniques have not taken longer to review and approve, and a generic does not have to use AM just because the brand does, but also that AM is not just for branded drugs.  The FDA has leaned into supporting the emerging technology program and engaging with generic and biosimilar manufacturers in many ways to improve supply chain resilience.

Dr. Corrigan-Curay offered a lot of information in a relatively short talk and touched on many points, such as inspection trends, recent guidances, and guidance updates, including a mention of the updated nitrosamines guidance.  Overall, her message on the directions the FDA is taking was quite positive and encouraging.  She closed with a key message that patient access requires resiliency, which for the FDA includes a focus on quality manufacturing.  The FDA is looking forward to working with industry to support access to generic and biosimilar medications, so let’s keep communications open and collaborate with the FDA to expand patient access together.