Access 2023: FDA’s Dr Jacqueline Corrigan-Curay Gives Updates on Biosimilar, Generic User Fee Programs

Throughout 2022, there were several updates to the Biosimilar and Generic Drug User Fee Acts (BsUFA and GDUFA, respectively), which enable the FDA to streamline development and approval of lower-cost medications, according to Jacqueline Corrigan-Curay, MD, JD, principal deputy center director of the FDA's Center for Drug Evaluation and Research, during her Access 2023 keynote address.

Access 2023, the annual meeting of the Association for Accessible Medicines, took place from February 13 to February 15, 2023, in Orlando, Florida.

Corrigan-Curay began with updates on savings from generic drugs, saying that generics generated $365 billion in savings in 2021, proving that more treatment choices and more competition results in lower drug costs. Savings from biosimilars totaled $7 billion in 2021.

She went into detail about the FDA’s new Biosimilar Curriculum for Healthcare Professional Programs, which includes a toolkit that can assist faculty in integrating biosimilars and interchangeable products into educational and professional training efforts for health care students. The goal of the program is to increase the knowledge and real-world application of concepts among students in health care degree programs. The FDA is also working with Medscape to create biosimilar-specific continuing education courses for health care professionals as well as offering patient-focused education materials in English and Spanish.

As part of the reauthorization of BsUFA (BsUFA III), Corrigan-Curay highlighted how the FDA is streamlining the biosimilar review process by establishing demonstration projects that seek to advance biosimilar development and improve the efficiency of biosimilar reviews.

“We also wanted to put this out to get public comment. We wanted to have something for people to react to. We have an open docket until April 5, and we hope you'll take that opportunity to really tell us what's important to you and what we should be focusing on,” said Corrigan-Curay.

Additionally, she addressed concerns about the implementation of the Inflation Reduction Act (IRA), which many worry will impact the utilization rates of lower-cost medications.

“I want to say 2 things about the Inflation Reduction Act. First, FDA, of course, is not implementing it, but we are providing technical assistance to our colleagues at CMS, so they understand our processes so they can understand the resources, and implement the Act in the way that it was designed. More importantly, this focus [of the IRA] is really on making sure that [FDA’s] regulatory review is efficient, consistent, and predictable. And…it's why we have a number of process improvements that are going into place for GDUFA III and BsUFA III.”

The FDA is working to modify the Biosimilar Initial Advisory meeting so the preliminary comparative analytical data are no longer required to meet FDA’s approval standards, which will make it easier for the FDA to review applications and companies looking to bring a biosimilar to the US market without compromising pharmaceutical safety.

“The other important theme I think in both BsUFA and GDUFA is continuing focus of science driving policy….The science and research program is quite strong and enables us to be proactive and adaptive in addressing future challenges and, therefore, facilitates access to modern medicines, especially in the complex generic space.”

Corrigan-Curay also teased some updates to BsUFA guidances that are expected over the next few years, including guidance for:

• Labeling interchangeable products (September 2023)
• Formal meetings with industry (September 2023)
• Classification of new supplement types (September 2023)
• Best practices in communication (December 2023)
• Device/presentation/container closures for interchangeable products (September 2025)

She provided insight into the FDA’s efforts to catch up on manufacturing facility inspections, including utilizing virtual inspections as well as mutual recognition agreements for foreign facilities. For biosimilars, Corrigan-Curay encouraged industry leaders to focus their efforts on understanding FDA inspections for biologics manufacturing and increasing quality of operations to support the approval of biologics.

“Medicines, of course, only work if patients have access….Access requires resiliency, which includes quality manufacturing, and we look forward to working with [industry leaders] on that. And we look forward to continuing to innovate and maintain a robust generic and biosimilar market as we implement all our commitments under GDUFA III and BsUFA III and we hope to exceed most of them.”