Patient Groups Applaud Senators for Raising Critical Patient Safety Questions about Biosimilars

PBSA calls for additional oversight and committee hearing to address patient safety concerns

(May 01, 2015) Patients for Biologics Safety & Access (PBSA), a coalition of over 20 patient advocacy organizations dedicated to protecting patient access to safe and effective biologics, today released the following statement regarding the letter from nine members of the U.S. Senate Committee on Health, Education, Labor and Pensions (HELP) sent to the Food and Drug Administration (FDA) urging the agency to provide clarity and certainty on the biosimilar drug approval process: 

“As representatives of millions of American patients and their families, we applaud Chairman Alexander and the members of the Senate HELP Committee for calling attention to critical issues facing the FDA’s approval of biosimilars. Clear guidance on the processes and standards from FDA is needed before additional biosimilars are approved. We remain concerned the FDA has yet to issue final guidance on a range of issues that will impact patient safety, including interchangeability, naming, and indication extrapolation.

“Our communities are eager for new and affordable treatments, but patients with rare and chronic diseases are keenly aware of the possible risks associated with biosimilars. Chairman Alexander and the members of the Senate HELP Committee have raised important questions with the FDA, and a full committee hearing should be held on biosimilars to ensure patient concerns are addressed.”

Chairman Lamar Alexander (R-TN) was joined by Sens. Michael Enzi (R-WY), Richard Burr (R-NC), Johnny Isakson (R-GA), Mark Kirk (R-IL), Orrin Hatch (R-UT), Pat Roberts (R-KS), Sen. Susan Collins (R-ME), and Bill Cassidy, M.D. (R-LA) in calling for final guidance from the FDA. The press release and ful letter can be viewed HERE.  

About Patients for Biologics Safety & Access

Patients for Biologics Safety & Access is a national coalition representing more than 20 patient advocacy organizations. The goal of the organization is to make sure the voices and interests of patients are heard as the FDA seeks to approve a new category of drugs known as biosimilars. For more information, visit www.BiosimSafety.org or @BiosimSafety

American Autoimmune Related Diseases Association

Arthritis Foundation

Committee of Ten Thousand

Crohn’s & Colitis Foundation of America

Dystonia Medical Research Foundation

GBS/CIDP Foundation International

Hemophilia Federation of America

Hepatitis Foundation International

Immune Deficiency Foundation

Jeffrey Modell Foundation

Lupus and Allied Diseases Association

Lupus Foundation of America

National Alliance on Mental Illness

National Organization for Rare Disorders

National Psoriasis Foundation

Platelet Disorder Support Association

Pulmonary Hypertension Association

Scleroderma Foundation

Spondylitis Association of America

United Spinal Association

US Hereditary Angioedema Association

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