All Things Biosimilars: How Streamlined CES Rules Could Shift the Market

In the special video podcast episode, produced in partnership with the Association for Accessible Medicines (AAM), co-hosts Giuseppe Randazzo, senior vice president of sciences and regulatory affairs at AAM, and Alex Keeton, the new executive director of AAM's Biosimilars Council, break down one of the most consequential policy shifts in the biosimilar landscape in years: the FDA’s new draft guidance on comparative efficacy studies (CES) and interchangeability.

Keeton opened the discussion by outlining how the agency’s updated scientific framework aims to streamline biosimilar development by reducing, and in many cases eliminating, the need for large, costly comparative efficacy studies. Instead, the FDA is formally recognizing that advanced analytical tools and pharmacokinetic data are often more sensitive and scientifically meaningful than clinical efficacy trials—an evolution that could save manufacturers years of development time and as much as $100 million to $300 million per program.

Randazzo emphasized the potential impact on access, noting that lower development costs can help expand competition and deliver more affordable biologic alternatives to patients. The hosts highlighted growing political momentum behind biosimilars following a recent press conference in which federal officials framed the guidance as a shift from bureaucracy to science. However, they also pointed to persistent policy gaps, including state-level substitution restrictions and the continued statutory existence of the interchangeable designation—an issue the hosts argued now requires Congressional action to align the law with current FDA science.

The conversation also addressed the “biosimilar void,” a term describing more than 100 biologics that are approaching patent expiration with no biosimilars in active development. Randazzo noted that reducing clinical trial requirements alone will not close this gap; challenges such as manufacturing complexity, market incentives, and payer-side barriers continue to slow progress.

Keeton and Randazzo closed by previewing a future episode dedicated entirely to payer dynamics, reinforcing that regulatory reform is only one piece of the broader effort to make biosimilars more accessible and sustainable across the US health care system.

Show notes

To learn more about the FDA draft guidance regarding clinical efficacy studies for biosimilars and interchangeability, click here.

To read more about G's discussion with Sarah Yim, MD, from the FDA from the recent 2025 GRx+Biosims conference, click here.

To read more on Yim's perspectives on biosimilar policy harmonization, click here.