FDA issued new draft guidance aimed at reducing the cost and complexity of developing biosimilar medicines, continuing a push to lower drug prices by streamlining the regulatory pathway for cheaper alternatives to expensive biologic therapies.

The Biologics Price Competition and Innovation Act of 2009 created the abbreviated approval pathway that biosimilars rely on, and the FDA has approved 82 biosimilars to date, with the new guidance is intended to make that pathway faster and less expensive.¹

"Streamlining biosimilar development reflects our ongoing commitment to lowering drug costs for everyday Americans," said FDA commissioner Marty Makary, M.D., M.P.H. "Using common sense, we are embracing more precise analytical testing approaches than have been used in the past."

What is the guidance proposing?

The draft guidance recommends eliminating certain clinical pharmacokinetic (PK) studies from the biosimilar development process when doing so is scientifically justified.¹ Specifically, it removes the previous requirement for at least one PK study directly comparing a proposed biosimilar with the U.S.-licensed reference product, allowing developers to instead use data from a comparator product approved outside the U.S. if the science supports it.

Along with the new draft guidance, the agency also updated its recommendations for scenarios in which clinical data from outside the U.S. can be used without an additional three-way PK study.¹

The FDA estimates the change could save biosimilar developers up to 50% of their PK study costs, or approximately $20 million per program.¹ The agency simultaneously withdrew its 2015 guidance on demonstrating bio-similarity, saying it no longer reflects the FDA's current scientific thinking after approving 82 biosimilars since that guidance was first issued.¹

Why does this matter for drug costs?

Biologic medicines are among the most expensive drugs on the market, commonly costing hundreds of thousands of dollars per year. Despite representing just 5% of all prescriptions, biologics account for 51% of total drug spending in the U.S., according to the FDA.²

Biosimilars, which function similarly to generic drugs for biologics, offer a pathway to more affordable treatment for conditions including cancer, rheumatoid arthritis, Crohn's disease, and diabetes, but their high development costs have historically slowed market entry.¹

How does this fit into the FDA's broader biosimilar strategy?

Today's announcement builds on a prior FDA effort from October, when the agency issued separate draft guidance reducing certain unnecessary comparative efficacy studies, a process that can take between one to three years and cost approximately $24 million.²

When FDA released the first draft guidance on biosimilars, FDA commissioner Makary noted the importance, saying, “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.”

Together, the two measures signal a sustained effort by the FDA to reduce the regulatory burden on biosimilar developers without compromising safety or efficacy standards.

Sources

1. FDA Takes Further Steps to Streamline Biosimilar Development and Make Medicines More Affordable U.S. Food and Drug Association March 9, 2026 https://www.fda.gov/news-events/press-announcements/fda-takes-further-steps-streamline-biosimilar-development-and-make-medicines-more-affordable
2. FDA proposes to ease testing rules to speed up biosimilar drug development Reuters March 9, 2026 https://www.reuters.com/business/healthcare-pharmaceuticals/fda-ease-testing-rules-speed-biosimilar-approvals-bloomberg-news-reports-2026-03-09/
3. New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4) U.S. Food and Drug Association March 9, 2026 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/new-and-revised-draft-qas-biosimilar-development-and-bpci-act-revision-4