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FDA public meeting on the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years 2018 through FY 2022

WASHINGTON, DC – During a public meeting held Friday by the Food and Drug Administration (FDA), the American College of Rheumatology (ACR) expressed its support for reauthorization of the Biosimilar User Fee Act (BsUFA) and called for performance goals that encourage greater transparency in biosimilar product naming and packaging to ensure patient safety.

 The BsUFA authorizes the FDA to assess and collect fees from the biopharmaceutical industry for biosimilar biological products, which the FDA uses to expedite the review process for these products. With current legislative authority for the BsUFA set to expire in September 2017, the FDA convened stakeholders to discuss BsUFA reauthorization and performance goals.

 Dr. Angus Worthing, a practicing rheumatologist and member of the ACR Government Affairs Committee, was invited to testify on behalf of the ACR during a Health Care Professionals Perspectives panel. Dr. Worthing’s testimony highlighted the importance of the BsUFA for rheumatology patients who rely on biologic therapies, saying the program helps bring safe, effective, and affordable biosimilars to market.  

 “We know that at least 1 in 6 people with rheumatoid arthritis already reduce their medication due to cost, potentially resulting in long-term joint damage,” Dr. Worthing testified.  “We physicians are extremely frustrated when we see our patients suffer because they can’t obtain or use the medicines as we have prescribed or as recommended by the FDA. We hope the anticipated decrease in cost resulting from the introduction of safe and effective biosimilars will increase access to these agents and improve the health of all who use them.”

The ACR also called on the FDA to make prompt and careful review of look-alike and sound-alike proprietary names and packaging labeling a top BsUFA performance goal going forward, urging the need for greater transparency in how biosimilar products are named and packaged. “This increased transparency will not only reduce medication errors, but also increase prescriber confidence in biosimilar safety and efficacy data, allowing for more extensive and robust pharmacovigilance programs,” said Dr. Worthing.

The testimony provided by the ACR reflects its current position statement regarding biosimilars, which states that safe and effective treatments should be available to patients at the lowest possible cost. It also states that any decisions regarding the approval of biosimilars must be driven by sound science. See the ACR’s position statement on biosimilars >

See the full ACR testimony from Friday's meeting >

Jocelyn Givens
404-633-3777, ext. 810
jgivens@rheumatology.org

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About the American College of Rheumatology

The American College of Rheumatology is an international medical society representing over 9,400 rheumatologists and rheumatology health professionals with a mission to Advance Rheumatology! In doing so, the ACR offers education, research, advocacy and practice management support to help its members continue their innovative work and provide quality patient care. Rheumatologists are experts in the diagnosis, management and treatment of more than 100 different types of arthritis and rheumatic diseases. For more information, visit www.rheumatology.org