WASHINGTON — The Biosimilars Council and the Association for Accessible Medicines applauded legislation, the Expedited Access to Biosimilars Act, introduced this week in the House of Representative by Nick Langworthy (R., N.Y.) and Kim Schrier, (D., Wash.), to codify the FDA's science-based approach to biosimilar review by limiting comparative efficacy studies.
AAM and the Biosimilars Council have long advocated for a more efficient, science-based biosimilar development pathway that reduces unnecessary development costs and risks, encourages continued investment in biosimilars, and expands patient access to lower-cost medicines.
“Clinical efficacy studies are not the most effective way to provide the FDA with comparative data between biosimilars and their reference biologics when more robust and more effective analytical, functional, and pharmacokinetic methodologies can provide these data,” said Alex Keeton, Executive Director of the Biosimilars Council.
The 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. Clinical efficacy studies should be the exception rather than a generally applied rule and explain the limited circumstances in which they might be scientifically justified.
The Expedited Access to Biosimilars Act will codify FDA’s guidance into law to ensure that the approval process is updated, safe, and predictable.
“Too often legacy regulations persist well beyond 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 “Outdated and less effective clinical studies waste time, slow approvals, and ultimately cost American patients more money.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 greatly thankful to Representatives Langworthy and Schrier for their leadership on this issue and their focus on cutting costs for patients, and the FDA for their continued and persistent work on this issue.”
