Sarah Yim, MD, director of the Office of Therapeutic Biologics and Biosimilars (OTBB), highlighted the ways the FDA is working to remove blocks and wedges hindering biosimilars.
Highlighting challenges and ongoing efforts, Sarah Yim, MD, director of the Office of Therapeutic Biologics and Biosimilars (OTBB) delivered a progress report on the FDA’s Biosimilars Action Plan (BAP) at the Association for Accessible Medicine (AAM) GRx+Biosims annual conference.
The BAP was created in 2018 to support biosimilar development by improving efficiency of the development and approval process; improving scientific and regulatory guidance; improving education about biosimilars for patients, clinicians, and payers; and improving the competitive environment by “reducing gaming of FDA requirements or other attempts to unfairly delay competition,” Yim said.
The FDA continues work to develop indices of critical quality attributes for biosimilars, identify pharmacodynamic (PD) biomarkers, and investigate in silico modeling, in which computers are used to model pharmacologic or physiologic processes. Each of these qualifies as a potential development tool, “but because of resource limitations related to [coronavirus disease 2019], we are not yet ready to release the first batch of biosimilar product recommendations. Hopefully, we’re close,” Yim said.
Setting the Exclusivity Clock
In 2014, the FDA released draft guidance to help biologics developers and other stakeholders to understand at what point the exclusivity protection clock begins to tick for a reference product. The guidance was also intended to help innovator companies know what information to provide the FDA to help the agency decide when product exclusivity begins. Six years later, that guidance is still in draft form, although progress continues, Yim said. “We’re still working on biologic product regulatory modernization and finalizing guidance on reference product exclusivity and post-approval manufacturing.”
The FDA would like to make various improvements to improve biosimilar development, and these include optimizing review staff time, exploring PD markers and assays that can help ascertain biosimilarity between biosimilar candidates and reference products, providing product specific guidance, and partnering with international regulatory authorities to reduce redundant activities. “To take product development and review to the next level in efficiency, more will need to be done,” Yim said.
“We’ll need to improve the status of biosimilar-related knowledge management and expand its scope to ensure not only consistency but provide space for ideas regarding improvements in best practices to be easily known and shared,” she said.
Another area of focus that could lead to important gains for biosimilars is patient education and reduction of anticompetitive messaging, she said. This can be achieved, in part, “by figuring out how to best exploit the educational gold mine of information that’s already available from real world experience with biosimilars. More than a decade of experience is available for some biosimilars in Europe, and at least several years of information should be available for some of the US-approved biosimilars.”
Purple Book Achievement
Yim noted the FDA’s achievement in modernizing the Purple Book, which originally was a bare bones listing of FDA-licensed biological products and now is an expanded, searchable, online database.
Also, in 2019, the FDA published guidance on biosimilar interchangeability with reference products and on the design and evaluation of comparative analytical studies for determining biosimilarity.
“We’ve made significant strides in advancing educational resources and activities and have recently begun a 2-year curriculum development project,” Yim said. “We also plan to begin work this year on developing additional, wide-reach education forums.”
Yim also said the FDA and the Federal Trade Commission have made “significant progress” combating anticompetitive behaviors by innovator companies and others that seek to oppose the advancement of biosimilars.
“Moving forward, we will be looking toward identifying and expanding high value activities that could help take biosimilar and interchangeable product access to the next level in the 2020s,” she said.
FDA and Industry Experts Unpack Biosimilar Device Requirements
October 23rd 2024At the GRx+Biosims 2024 conference, a panel of industry experts and FDA officials discussed evolving device requirements for biosimilars and interchangeable biosimilars, highlighting new approaches to comparative use human factors studies, regulatory challenges, and alternative validation methods.
Insights from Festival of Biologics: Dracey Poore Discusses Cardinal Health’s 2024 Biosimilar Report
May 19th 2024The discussion highlights key emerging trends from the Festival of Biologics conference and the annual Cardinal Health Biosimilars Report, including the importance of sustainability in the health care landscape and the challenges and successes in biosimilar adoption and affordability.
Unifying Standards: The Need for Streamlined Biosimilar Development
October 22nd 2024At the 2024 GRx+Biosims conference, industry leaders and regulatory experts underscored the urgency of unifying global standards and simplifying the biosimilar development process, sharing insights on recent advancements and the necessity for greater collaboration between manufacturers and regulatory agencies.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
Revolutionizing Biopharmaceuticals: The EU's Biosimilar Success and Remaining Challenges
October 16th 2024The European Union's (EU) approach to biosimilars has revolutionized the biopharmaceutical market by driving innovation, lowering costs, and increasing adoption; however, there remains a need for more education, real-world evidence, and efforts to address challenges to enhance patient access and affordability.