Kimberly Maxfield, PhD, of the FDA discussed actions been taken by the FDA since President Biden's reauthorization of the Biosimilar User Fee Act (BsUFA) III last year, as well as what they plan to achieve through 2027.
Kimberly Maxfield, PhD, of the FDA discussed what actions have been taken by the FDA, and what they plan to achieve over the next 4 years, since President Biden reauthorized the Biosimilar User Fee Act (BsUFA) III last year through 2027. She also explained the BsUFA III demonstration projects and their impact on the biosimilar industry.
At the FDA, Maxfield currently serves as the scientific lead on the BsUFA III regulatory research pilot program in the Office of Therapeutic Biologics and Biosimilars (OTBB). Also, at AMCP Nexus on October 17, she further discussed biosimilars during the session, "Biosimilar Operational Readiness: Marketplace Trends and Regulatory Considerations."
Since President Biden reauthorized BsUFA III last year through 2027, what actions has the FDA taken with this funding so far? What does it plan to achieve over the next 4 years?
BsUFA III included a lot of different enhancement areas, and that's all outlined in the commitment letter, which is public online. Some of the things that we've done thus far is there's been additional meeting types that biosimilar developers can request that are related to how much data you have when you submit the request. Additionally, for BIA [Biosimilar Initial Advisory] meetings, those previously had requirements for analytical data and now no longer has those requirements.
Additionally, we have met some of the requirements involving the reg sci program [the regulatory science pilot program], which I know we'll talk about a little bit later. The other commitment that we've achieved so far is the labeling guidance, so a new labeling guide is labeling for biosimilar products has come out at the end of August, and that was a commitment; the major highlight there would be the interchangeability statement is now no longer a part of the labeling.
What do the BsUFA III demonstration projects entail? What impact will they ultimately have on the biosimilar industry?
The demonstration projects are part of the regulatory science pilot program commitment. So, the commitment was for the FDA to explore areas and fund support areas that will enhance the regulatory decision making and scientific recommendations in regards to biosimilar development and interchangeable development.
As part of that letter, as part of that commitment, there are 2 aims or demonstration projects. The first is advancing the development of interchangeable products, and the second is increasing the efficiency of biosimilar development. Those were our starting point for the reg sci program where we have now since defined regulatory impacts and research priorities to inform our efforts to move that forward.