FDA Commissioner Makary joined AAM’s GRx+Biosims 2025 conference today
WASHINGTON (October 29, 2025) — The Association for Accessible Medicines, the trade association representing America’s manufacturers of generic and biosimilar medicines, and its Biosimilars Council, today applauded the announcement by the Food and Drug Administration to streamline approval processes for biosimilar medicines. FDA Commissioner Makary spoke earlier today at AAM’s annual GRx+Biosims 2025 regulatory conference in North Bethesda, MD.
“We are grateful to Commissioner Makary for joining us at GRx+Biosims today and sharing with us the Trump Administrations plans to streamline approvals for biosimilars which will lower costs for patients,” said John Murphy III, President and CEO of the Association for Accessible Medicines and the Biosimilars Council. “The Biosimilars Council has focused on the interchangeability designation and clinical efficacy study reform as our industry’s top two regulatory priorities, and today’s announcement creates regulatory relief and efficiencies for our members and bring lower-cost biosimilars to market faster.”
Today, Department of Health and Human Services Secretary Robert F. Kennedy, Jr., Administrator for the Centers for Medicare & Medicaid Services Dr. Mehmet Oz, and Food and Drug Administration Commissioner Dr. Martin Makary held a press conference, Accelerating Competition to Lower Drug Prices, to outline several actions the Trump Administration is taking to combat pharmaceutical prices which includes a focus on streamlining the approval of biosimilar medicines. Biosimilars are the generic version of biologic medicines and have no meaningful clinical differences from the reference medicine.
“Brand drug companies use the arbitrary interchangeability designation to delay or block access to lower-cost biosimilar medicines, which results in fewer choices for patients and billions of dollars in missed savings for the U.S. healthcare system,” said Alex Keeton, Executive Director of the Biosimilars Council and Senior Vice President of Policy. “The U.S. is the only country in the world with this unnecessary ‘interchangeable’ designation, and the FDA agrees that it is unnecessary. Clinical efficacy studies are not the most effective way to provide the FDA with comparative date between biosimilars and their reference biologics when more updated analytical, functional, and pharmacokinetic methodologies can detect any clinically meaningful differences.”
The Administration announced a streamlined and improved program for clinical efficacy studies. AAM and the Biosimilars Council have long called for clarifications in the current guidance and seek faster, more efficient comparative methods. Doing so will reduce the costs and risks of biosimilar development and encourage industry investment in biosimilars.
Also announced today, the unnecessary and confusing biosimilar interchangeability designation should be removed, and the FDA should continue their practice or treating any approved biosimilar as interchangeable. Interchangeability is a legislative term, not a scientific term, and no other country in the world has this arbitrary distinction. However, this designation currently requires additional hurdles and cost for biosimilar approvals.
Earlier today at GRx+Biosims 2025, Commissioner Makary said, “Every biosimilar should have the designation of interchangeable. We need more biosimilars on market. We need to cut the red tape for biosimilars and we need to recognize that biosimilars have the promise of lowering drug prices, a major priority in this administration and improving access for patients who otherwise can’t get access. The fundamental problem in healthcare is that we have non-competitive markets and we want to convert those to competitive markets.”
GRx+Biosims 2025 is AAM’s annual regulatory conference and is the leading science, regulatory and policy event for the U.S. generic and biosimilar medicines industry.
Position Paper: More Efficient Regulatory Pathways for Critical Medicines
Blog: Breaking Down the Interchangeability Barrier
Blog: What Are Interchangeable Biologics?
For media inquiries, contact media@accessiblemeds.org.
About AAM
The Association for Accessible Medicines, your generics and biosimilars industry, is driven by the belief that access to safe, quality, effective medicine has a tremendous impact on a person’s life and the world around them. AAM represents the manufacturers of finished generic pharmaceuticals and biosimilars, manufacturers of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals are 90 percent of prescriptions dispensed in the U.S. but only 12 percent of total drug spending.
About the Biosimilars Council
The Biosimilars Council, a division of the Association for Accessible Medicines, works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is the leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, government affairs, legal affairs, and regulatory policy. More information is available biosimilarscouncil.org.
