WASHINGTON, D.C. — The U.S. Food and Drug Administration has announced a series of measures intended to reduce the time and expense required to develop biosimilar drugs—lower-cost alternatives to biologic medications used to treat serious and chronic illnesses.
The FDA’s new draft guidance, titled “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies,” proposes eliminating most comparative human clinical studies in favor of analytical testing to demonstrate biosimilarity. The agency says the change will accelerate development while maintaining safety and effectiveness standards.
“Biosimilars are often far more affordable to patients and have the promise to significantly lower health care costs in America,” said FDA Commissioner Marty Makary, M.D., M.P.H. “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.”
Health and Human Services Secretary Robert F. Kennedy Jr. called the update part of President Trump’s effort to lower prescription drug prices. “For too long, a burdensome approval process has kept patients from accessing more affordable biosimilars,” Kennedy said. “This bold action by the FDA accelerates biosimilar development, drives market competition, and expands patient options.”
The FDA also announced plans to make it easier for biosimilars to be developed as interchangeable with brand-name biologics. In most cases, the agency will no longer recommend additional “switching studies,” which have previously been required for some interchangeable biosimilars but not for generic drugs.
Biologic drugs account for only about 5% of U.S. prescriptions but represent more than half of total drug spending. Although the FDA has approved 76 biosimilars since 2015, they make up less than 20% of the market. The agency hopes its new approach will help more companies bring affordable, high-quality biosimilars to market.
The FDA’s new guidance and related materials are available for public comment on its website.
