Washington, D.C., August 20, 2024 – The ERISA Industry Committee (ERIC) today praised draft guidance (Guidance) by the U.S. Food and Drug Administration (FDA) that will help increase competition in the prescription drug markets, boosting the availability of affordable biosimilar drugs. The Guidance removes the FDA switching study requirement and provides updated recommendations for demonstrating that a biosimilar product is interchangeable with a reference product.
“As drug costs continue to rise, employers are constantly searching for ways to more quickly bring affordable drugs to workers and their families,” said Melissa Bartlett, ERIC’s Senior Vice President of Health Policy. “Biosimilars can provide that injection of much-needed affordability, but only if they are accessible to consumers. ERIC applauds FDA’s action to update its guidance because it recognizes the switching study requirement for what it is – a hurdle that for too long has delayed and prevented competition to biosimilars.”
The FDA’s current rules on interchangeability can create barriers to bringing biosimilars to market due to stringent requirements for extensive evidence and clinical studies demonstrating that a biosimilar is interchangeable with a reference product. Based on new insights and published research, the guidance addresses the outdated belief that biosimilars without interchangeability designations are less safe and effective.
In 2020, ERIC launched a groundbreaking initiative to better understand the role that biosimilars could play in reducing health care costs, and found that biosimilars saved employers, employees, and their families significant amounts of money. ERIC strongly supports federal legislation that would remove the interchangeability designation altogether, including the Biosimilar Red Tape Elimination Act (S. 2305) sponsored by Senators Mike Lee (R-UT), Ben Ray Lujan (D-NM), Mike Braun (R-IN), and J.D. Vance (R-OH). The bipartisan legislation would increase access and affordability of biosimilars by eliminating the switching studies that delay interchangeability.
Read ERIC’s comment letter here.