WASHINGTON — The Biosimilars Council and the Association for Accessible Medicines sent a follow up letter to U.S. Senate and House health committee leaders in support of the Biosimilar Red Tape Elimination Act. The letter was signed by over three dozen leading advocacy groups representing health care, patients, consumers, employers, taxpayers, and policy think tanks.
The group sent a letter of support this past July. Since then, bicameral, bipartisan legislation has been introduced and FDA Commissioner Marty Makary announced plans to finalize guidance eliminating the requirement for switching studies and reiterated the FDA’s recommendation that Congress remove this unnecessary distinction.
“There is no clinically meaningful difference between biosimilar and interchangeable biosimilar medicines. Interchangeability is a designation created by legislative language instead of science, doesn’t exist in any other country,” said John Murphy III, President and CEO of AAM. “We are thankful to the bill sponsors in the House and the Senate as well as the many groups who have joined us.”
The letter reads: “Now that there has been bicameral, bipartisan introduction of the Biosimilar Red Tape Elimination Act by Representatives August Pfluger (R-TX) and Greg Landsman (D-OH) (H.R. 5526) as well as Senators Mike Lee (R-UT), Ben Ray Lujan (D-NM), Rand Paul (R-KY), and Maggie Hassan (D-NH) (S. 1954), on behalf of patients, providers, taxpayers, and consumers, we urge you to advance this crucial legislation. The Biosimilar Red Tape Elimination Act would remove the distinction between biosimilars and interchangeable biosimilars. In doing so, the legislation would increase patient access to essential biosimilar medications and reduce healthcare costs.”
Alex Keeton, Executive Director Biosimilars Council said, “The Biosimilars Council welcomes this positive momentum and calls on Congress to pass the Biosimilar Red Tape Elimination Act. This will clear up confusion, streamline the approval process, and get critical medicines to patients faster.”
Since biosimilars first entered the market in 2015, they have generated savings of more than $56 billion and have been used in more than 3.3 billion days of patient therapy with no clinically meaningful differences in patient safety or outcomes. Biosimilar competition has expanded patient access by nearly 500 million days of therapy.
Dr. Yim Sarah Yim, M.D., director of the FDA’s Office of New Drugs’ Office of Therapeutic Biologics and Biosimilars, pointed at our GRx+Biosims conference, “Put simply, an interchangeable designation only impacts ease of access, not the quality of the drug.”
The letter continues, “Unfortunately, the statutory distinction between biosimilars and interchangeable biosimilars continues to generate confusion and misinformation about the safety of biosimilar medicines. The Food and Drug Administration (FDA) has consistently affirmed that there is no scientific difference between biosimilars and interchangeable biologics. Most recently, FDA Commissioner Marty Makary, M.D., M.P.H., announced the Agency’s intent to finalize guidance eliminating the requirement for switching studies and reiterated the FDA’s recommendation that Congress remove this unnecessary distinction. The Biosimilar Red Tape Elimination Act is consistent with FDA’s science-based recommendation and represents an important step toward building confidence and streamlining patient access to biosimilar medicines.”
The letter was sent to Senators Cassidy, M.D. (R-LA) and Sanders (I-VT), chair and ranking member of the Senate Health Committee, and Representatives Guthrie (R-AL) and Pallone (D-NJ), chair and ranking member of the U.S. House Committee on Energy & Commerce.
The letter is signed by: Academy of Managed Care Pharmacy; AffirmedRx; AHIP; Allergy & Asthma Network; Alliance of Community Health Plans; Americans for Prosperity; American Society for Health-System Pharmacists; Blue Cross Blue Shield Association; Blue Shield of CA; Campaign for Sustainable Rx Pricing; CancerCare; Consumer Action; CVS Health; Economic Alliance for Michigan; Heartland Impact; Heritage Action for America; Kaiser Permanente; LIBRE Initiative; National Alliance of Healthcare Purchaser Coalitions; National Association of Chain Drug Stores; National Association of Hispanic Nurses; National Consumers League; National Hispanic Health Foundation; National Patient Advocate Foundation; Prime Therapeutics; Public Citizen; Public Sector HealthCare Roundtable; Spina Bifida Association; Taxpayers Protection Alliance; The Bipartisan Policy Center; The ERISA Industry Committee; The Heartland Institute; The Mended Hearts, Inc.; The R Street Institute; Transparency-Rx; U.S. PIRG; Washington Health Alliance.
