The U.S. Food and Drug Administration (FDA) has released a new draft guidance to streamline the development of biosimilars. This, and prior versions of the draft guidance for industry, reflect actions being taken by the agency to lower the cost of drugs.
“Streamlining biosimilar development reflects our ongoing commitment to lowering drug costs for everyday Americans,” stated FDA Commissioner Marty Makary, MD, MPH. “Using common sense, we are embracing more precise analytical testing approaches than have been used in the past.”
Background
The Biologics Price Competition and Innovation (BPCI) Act of 2009 created an abbreviated licensure pathway, or pathway to approval, to allow patients to access safe and effective alternative biological products at reduced prices. A total of 82 biosimilars have been approved by the FDA to date for various conditions, including cancer.
In October 2025, the FDA announced additional simplifications to biosimilar drug development by reducing costly, time-consuming comparative human efficacy studies. The agency said that instead, analytical testing would be sufficient to prove product differences.
The FDA also moved to withdraw the April 2015 final guidance for "Scientific Considerations in Demonstrating Biosimilarity to a Reference Product," as it is no longer indicative of the FDA's approach to biosimilar drug development.
Changes in Revised Guidance
The FDA recommended, in this fourth revision of the biosimilar draft guidance, that drug developers streamline unnecessary clinical pharmacokinetic testing when scientifically justified. This change could save biosimilar developers up to 50% of their pharmacokinetic study costs, or approximately $20 million, and help lower drug costs.
Additionally, the revised guidance reflects changes to policy regarding non–U.S.-licensed comparator products. The revised draft notes that clinical data from a non–U.S.-licensed product can be used for comparative data, in certain circumstances, and that the non–U.S.-licensed product does not require a separate investigational new drug application for a development program.
