Legislative progress codifies FDA's science-based approach to biosimilar review by limiting comparative efficacy studies; Eliminates arbitrary distinction between interchangeable biologics and biosimilars
WASHINGTON — The Biosimilars Council and the Association for Accessible Medicines have lauded legislative progress as the House Energy and Commerce Committee marked up and voted to approve the Expedited Access to Biosimilars Act and the Biosimilars Red Tape Elimination Act. These bills were passed out of the committee unanimously and are now ready for a vote by the full House or Representatives. The Biosimilars Red Tape Elimination Act was voted out of the Senate Health Committee last week and is also ready for a vote of the full Senate.
“AAM and the Biosimilars Council thank the House E&C Committee, and especially Reps. Langworthy, Pfluger, Landsman, and Schrier for their persistent leadership and hard work to improve patient access and savings as well as strengthen the generic and biosimilar medicines supply chain,” said John Murphy III, President and CEO of AAM. “Legacy rules and regulations too often persist beyond their usefulness and can cause harm to patients and the healthcare system. We applaud the House and Senate for moving these two bills forward.”
The Expedited Access to Biosimilars Act, introduced last week in the U.S. House of Representative by Representatives Nick Langworthy (NY-23) and Kim Schrier, M.D. (WA-08), codifies 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.
The Biosimilar Red Tape Elimination Act, sponsored by Representatives Pfluger (R-TX) and Landsman (D-OH), removes the arbitrary and unscientific distinction between biosimilars and interchangeable biologics. This legislation 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.
Alex Keeton, Executive Director of the Biosimilars Council added, “There is no clinically meaningful difference between biosimilars and interchangeable biosimilars. The U.S. is the only country in the world with this unnecessary designation, and the FDA agrees that it is unnecessary. Also, less effective and outdated clinical studies slow approvals and ultimately cost patients time and money. Clinical efficacy studies are not the most effective way to provide the FDA with comparative data when more robust and more effective analytical, functional, and pharmacokinetic methodologies can provide these data.”
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 conference, stating that, “Scientifically, biosimilars and interchangeables are really not distinguishable.” Put simply, as it currently stands, interchangeable designation only impacts ease of access, not the quality of the drug.
Biosimilars have been used in over 3.3 billion days of patient therapy in the U.S. since 2015 and have expanded patient access to care by more than 495 million days of therapy.
