Biologics

FDA Signals Pragmatic Push to Ease Biosimilar Development

FDA Office of Therapeutic Biologics and Biosimilars (OTBB) director Sarah Yim said the agency is focused on making biosimilar development faster and more predictable — without undermining scientific rigor. Referencing recent analyses on rising development costs, Yim warned: “If biosimilar development becomes too costly, that’s a problem,” and stressed a shift toward eliminating “nice-to-have” requirements that do not materially advance product evaluation. Yim made the remarks during a fireside chat this week at the GRx+Biosims 2025 conference, hosted by the Association for Accessible Medicines (AAM), according to an AAM online recap.

Coincidentally, FDA just proposed a major shift in how biosimilars are evaluated, signaling that many products may no longer need traditional comparative clinical efficacy studies to demonstrate biosimilarity. Outlined in a new draft guidance, Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies, the policy shift reflects the agency’s growing confidence in advanced analytical technologies and pharmacokinetic data in lieu of requiring clinical efficacy studies in certain instances (see earlier story).

Affordability and access remain central to FDA’s mission, Yim said. “We have to make it feasible for developers to pursue biologics beyond the Humiras of the world,” she noted, arguing that a sustainable pathway must extend to lower-volume therapeutic categories.

Looking ahead, Yim highlighted several policy areas under active review:

Global harmonization. FDA is collaborating through the International Council for Harmonization on multidisciplinary biosimilar guidance to reduce duplication and ensure continuity as scientific standards evolve.
Program structure. As the biosimilars portfolio expands, Yim said OTBB may eventually require restructuring — potentially including its own signatory authority — to keep pace. “As the biosimilars program grows, it’s getting harder to contain within OND [Office of New Drugs],” she said, framing the issue as one that may require congressional action.
Reducing unnecessary studies. The agency is reevaluating the need for comparative efficacy studies in many cases and looking to codify lessons learned so turnover does not lead to regulatory backtracking.
Naming suffixes. The decade-old suffix requirement remains under review, though changing course may require extensive new data.
Interchangeability. Yim reiterated that FDA regulates all biosimilars to the same scientific standard, calling interchangeability a matter of “recognizing the difference” without raising the evidentiary bar.
Use of global comparators. While U.S. statute continues to limit the use of ex-U.S. reference products, Yim pointed to creative bridging strategies and synthetic data models as avenues to reduce redundant testing.

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