(March 06, 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 FDA approval of Zarxio, the first biosimilar to be approved in the United States:

“While PBSA commends the FDA on its milestone approval of the first biosimilar in the United States, we are still concerned that the FDA has approved the first biosimilar without having first put in place critical policies that safeguard patients. To date, and contrary to its own policy of transparency, FDA has not published any final standards. The Agency has yet to issue final guidance on a range of issues that will impact patient safety including interchangeability, naming, and indication extrapolation.

“Transparency is essential to build patient confidence in this new category of drugs. It is vital that the FDA have a transparent process so that patients and the public have an opportunity to review and comment upon these standards before they are adopted.

“While our communities are eager for new and affordable treatments, patients with rare and chronic diseases are keenly aware of the possible risks associated with biosimilars. Although the FDA approved Zarxio, the implications and decisions extend beyond the first biosimilar approval, we still need clear guidance on the processes and standards from FDA as additional biosimilars are approved.”

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