Calling for Unified Biosimilar Standards, Stronger Education at GRx+Biosims

During a fireside chat at the GRx+Biosims conference, Sarah Yim, MD, director of the FDA’s Office of Therapeutic Biologics and Biosimilars (OTBB), stressed the need for stronger education efforts and industry collaboration to boost trust and streamline the path to biosimilar adoption.¹

Moderated by Giuseppe Randazzo, senior vice president of sciences and regulatory affairs at the Association for Accessible Medicines, the discussion traced the path biosimilars have taken in the regulatory landscape and explored critical legislative and industry dynamics shaping the future of biosimilars. The GRx+Biosims conference is taking place October 21 to 23, 2024, in Rockville, Maryland.

Yim reflected on the initial uncertainty surrounding biosimilars when they first entered the market, acknowledging that understanding of these products has greatly evolved. She emphasized the industry's efforts to ensure that biosimilars closely resemble their reference products, both analytically and clinically. According to Yim, biosimilars show minimal differences from reference biologics, with no significant safety concerns, helping to build trust in their use among health care providers and patients.

Prior to her work at the FDA, Yim was a clinical fellow at the National Institutes of Health’s National Institute of Arthritis and Musculoskeletal and Skin Disease and served as a medical officer for the US Army for over 10 years. | Image credit: Skylar Jeremias

The conversation moved to the legal and regulatory framework governing biosimilars, particularly the designation of interchangeability. Yim stressed the FDA’s commitment to adhering to the law while also considering potential reforms to streamline these standards. She discussed the proposal to remove the distinction between biosimilars and interchangeable products, explaining how a unified determination could simplify the regulatory process. This move, Yim noted, could help reduce barriers for biosimilar developers while maintaining patient safety and product efficacy.

On the subject of comparative efficacy studies, which many experts have called for the FDA to remove,² Yim explained a disconnect within the agency between clinical and analytical data, pointing out that not all stakeholders have the same level of experience with biosimilars.

“I think what you're coming across is varying levels of experience and comfort [with biosimilars], right? There're a lot of folks who tend to be a little more conservative, and they want things to be clinical data driven. I think we're trying very hard to send out a message to everybody about how essential biosimilars are and how there's a public health need to streamline to reduce the burden of biosimilar development and get more of these products out to patients,” Yim explained.

Randazzo then asked about the potential reorganization of the OTBB into a more autonomous supervisory role. Yim discussed the benefits and challenges of such a change, emphasizing that efficiency would be key in ensuring faster and more cohesive regulatory reviews. Future reorganizations could further improve the agency’s capacity to handle biosimilar applications, Yim suggested.

Turning to global considerations, Yim addressed the hurdles in biosimilar development across multiple jurisdictions, where companies must conduct separate reference studies for each market. She noted the possibility of legislative changes to harmonize these requirements and highlighted the importance of maintaining scientific rigor while pursuing greater efficiency.

The FDA's international collaboration was also a focus of the chat, with Yim sharing progress made through partnerships with organizations like the World Health Organization and the International Pharmaceutical Regulators Programme. She stressed the importance of a global framework to identify when comparative efficacy studies are necessary, which could streamline biosimilar approval processes across borders.

In terms of public outreach and education, Yim underscored the FDA’s multifaceted approach, including continuing education for health care providers, updates to medical school curriculums, and efforts to engage the general public through social media and informational resources. Convincing health care providers to instill confidence in biosimilars with their patients is crucial, Yim added, as their support can significantly affect adoption rates.

Yim also emphasized the importance of collaboration between the FDA and the pharmaceutical industry, particularly in identifying gaps in public policy and educational materials. She praised the industry’s role in advancing biosimilars through lobbying efforts and public policy initiatives, recognizing the potential for these partnerships to move legislative reforms forward.

As the fireside chat concluded, Yim reiterated the importance of collaboration and education in advancing the biosimilar market. Looking ahead, she highlighted ongoing efforts to streamline biosimilar development and foster greater understanding among both health care professionals and the public.

Randazzo and Yim will both be participating in this year's Global Biosimilars Week webinar, hosted by The Center for Biosimilars^® and organized by the International Biosimilars and Generics Association. The webinar is being held on November 13, 2024 at 9:00am EST.

For more information on how to register, click here.

References

1. Randazzo G, Yim S. Biosimilars keynote address fireside chat. Presented at: GRx+Biosims; October 21-23, 2024; Rockville, Maryland.

2. Jeremais S. Part 2: FDA workshop shares manufacturer perspective on the value of clinical efficacy testing. September 18, 2023. Accessed October 22, 2024. https://www.centerforbiosimilars.com/view/part-2-fda-workshop-shares-manufacturer-perspective-on-the-value-of-clinical-efficacy-testing