Legislation codifies FDA’s science-based approach to biosimilar review by limiting comparative efficacy studies; Introduced and Passed House Committee This Week
WASHINGTON — The Biosimilars Council and the Association for Accessible Medicines today thanked the Senate HELP Committee for marking up and passing the Expedited Access to Biosimilars Act. This legislation will codify FDA’s science-based approach to biosimilar review by limiting comparative efficacy studies. AAM and the Biosimilars Council have long called for clarifications in the current guidance and seek faster, more efficient comparative methods. The Expedited Access to Biosimilars Act will reduce the costs and risks of biosimilar development and encourage industry investment in biosimilars.
“Legacy regulations can often outlive their usefulness,” said John Murphy III, President and CEO of AAM. “Outdated and less effective clinical studies waste time, slow approvals, and ultimately cost American patients more money. We are thankful to Senators Rand Paul of Kentucky and Maggie Hassan of New Hampshire for their leadership and focus on cutting costs for patients, and we appreciate the FDA for their continued and persistent work on this issue.”
Similar legislation was passed by the House Energy and Commerce Committee this week, sponsored by Congressman Nick Langworthy (NY-23) and Congresswoman Kim Schrier, M.D. (WA-08). The Expedited Access to Biosimilars Act is now ready for a vote in the full Senate as well as the full House of Representatives.
“Comparative efficacy studies are rarely necessary to demonstrate biosimilarity, and eliminating unnecessary comparative efficacy studies isn’t just good science —it brings patients more affordable biosimilar options, faster,” said Alex Keeton, Executive Director of the Biosimilars Council. “The science is clear when it comes to utilizing clinical data.”
The Biosimilars Council and AAM have long supported eliminating unnecessary comparative clinical efficacy studies. Doing so will reduce unnecessary development costs and risks while encouraging greater biosimilar competition. Comparative efficacy studies should be the exception rather than a generally applied rule and explain the limited circumstances in which they might be scientifically justified. FDA rightly codified discouraging comparative efficacy studies when analytical, functional, and PK methodologies are sufficient to detect clinically meaningful differences.
The Expedited Access to Biosimilars Act will codify FDA’s guidance into law to ensure that the approval process is updated, safe, and predictable.
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