FDA is taking aim at expensive biologic drugs.

The agency announced new draft guidance to simplify biosimilarity studies and reduce clinical testing that it has deemed “unnecessary.”¹ The goal of these moves, according to the agency, is to make it easier for pharmaceutical companies to develop biosimilars.

What impact will FDA's actions have on biosimilar development?

FDA says that this will bring more low-cost alternatives to the market at a faster, more reliable rate. The new guidance is titled “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies.”

In a press release, Health and Human Services Secretary Robert F. Kennedy Jr. said, “Today’s announcement of biosimilar reform furthers President Trump’s directive to lower drug prices for the American people. Biologics treat many chronic diseases, but for too long, a burdensome approval process has kept patients from accessing more affordable biosimilars. This bold action by the FDA accelerates biosimilar development, drives market competition, expands patient options, and advances our mission to Make America Healthy Again.”

FDA Commissioner Marty Makary, MD, MPH, added, “Biosimilars are often far more affordable to patients and have the promise to significantly lower health care costs in America. By streamlining the biosimilar development process and helping advance interchangeability, we can achieve massive cost reductions for advanced treatments for cancer, autoimmune diseases, and rare disorders affecting millions of Americans.”

The new guidance no longer requires developers to conduct comparative human clinical studies and will instead direct the agency to accept analytical testing. FDA will also generally not recommend switching studies.

“Science continues to evolve, and the FDA remains committed to advancing common-sense policies that further promote efficient and effective biosimilar and interchangeable biosimilar development, without compromising safety and effectiveness,” said George Tidmarsh, M.D., Ph.D., Director, FDA Center for Drug Evaluation and Research.

This is the latest effort from FDA to address public health concerns.

In September, the agency announced reforms designed to address what it considers to be misleading direct-to-consumer (DTC) advertising.² In a statement, the agency referenced digital advertising found on social media and undisclosed paid influencer promotions as distorting patients’ ability to distinguish between actual medical advice and promotional material.

At the time of the announcement, FDA said it was issuing 100 cease-and-desist letter to companies it had determined were running deceptive ads. The agency also said it was sending out thousands of letters to other pharmaceutical companies to warn them about potentially misleading ads.

In a press release, Secretary Kennedy said, “Pharmaceutical ads hooked this country on prescription drugs. We will shut down that pipeline of deception and require drug companies to disclose all critical safety facts in their advertising. Only radical transparency will break the cycle of overmedicalization that drives America’s chronic disease epidemic.”

In the same release, Commissioner Makary added, “For far too long, the FDA has permitted misleading drug advertisements, distorting the doctor-patient relationship and creating increased demand for medications regardless of clinical appropriateness. Drug companies spend up to 25% of their budget on advertising. Those billions of dollars would be better spent on lowering drug prices for everyday Americans.”

Sources

1. FDA Moves to Accelerate Biosimilar Development and Lower Drug Costs. FDA. October 29, 2025. https://www.fda.gov/news-events/press-announcements/fda-moves-accelerate-biosimilar-development-and-lower-drug-costs
2. Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies. FDA. October 29, 2025. https://www.fda.gov/media/189366/download
3. FDA Launches Crackdown on Deceptive Drug Advertising. FDA. September 9, 2025. Accessed October 29, 2025. https://www.fda.gov/news-events/press-announcements/fda-launches-crackdown-deceptive-drug-advertising