The Biosimilar Council Applauds Bipartisan Senate Legislation To Eliminate The Arbitrary Distinction Between Interchangeable Biologics And Biosimilars

Proposal would reduce brand misinformation and remove unnecessary requirements that block patient access to biosimilar medicines

The Biosimilars Council, the leading trade association representing manufacturers of biosimilar medicines, today applauded the bipartisan introduction of the Biosimilar Red Tape Elimination Act in the United States Senate. The legislation, sponsored by Senators Lee (R-UT) and Luján (D-NM), removes the arbitrary and unscientific distinction between biosimilars and interchangeable biologics.

“As the FDA has made clear, there is no clinically meaningful difference between biosimilars and interchangeable biosimilars,” said John Murphy, President and CEO of the Association for Accessible Medicines. “Yet the U.S. remains the only country in the world with this additional, unnecessary designation – one that brand-name drug companies have exploited to delay or block access to lower-cost biosimilar treatments. This results in fewer choices for patients and billions of dollars in missed savings for the U.S. healthcare system. The Biosimilar Red Tape Elimination Act will expand competition and savings for patients and taxpayers, while preserving FDA’s ability to ensure the safety and efficacy of medicines for America’s patients. The Biosimilars Council and AAM thank Senators Lee and Luján for their work on behalf of American patients and we look forward to working with Congress to eliminate this outdated and unnecessary barrier to lower-priced biosimilar medicines.”

The Biosimilar Red Tape Elimination Act is consistent with the FDA’s recommendation to remove the statutory distinction between biosimilars and interchangeable biologics, while retaining FDA’s authority to ensure the safety and efficacy of biosimilar medicines. This distinction, which is not based on any scientific differences between the products, has resulted in brand misinformation, patient and provider confusion, and ultimately, hindered biosimilar adoption. Of note, FDA has emphasized that there is no scientific difference between biosimilars and interchangeable biologics through numerous educational offerings for providers and patients, including an article published in JAMA. No other country in the world uses this arbitrary designation.

Dr. Yim Sarah Yim, M.D., director of the FDA’s Office of New Drugs’ Office of Therapeutic Biologics and Biosimilars, affirmed that, “there may be inaccurate perceptions that interchangeable biosimilars are safer or more effective than biosimilars that are not approved.” She furthered that point at our GRx+Biosims 2023 conference in October, stating that, “Scientifically, biosimilars and interchangeables are really not distinguishable.” Put simply, an interchangeable designation only impacts ease of access, not the quality of the drug.

Biosimilars have been used in over 2.7 billion days of patient therapy in the U.S. and have expanded patient access to care by more than 495 million days of therapy.

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 a 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, strategic partnerships, government affairs, legal affairs and regulatory policy. For more information, visit www.biosimilarscouncil.org.