(August 27, 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to protecting patient access to safe and effective biologics, today released the following statement regarding the draft guidance on the naming of biosimilars and biologics put forward today by the Food and Drug Administration (FDA):

“Patients for Biologics Safety and Access (PBSA) are pleased with the FDA’s commitment to unique non-proprietary names of biosimilars.  Unique distinguishable names for all biological medications are needed to ensure accurate tracking of medication utilization and adverse events, reduce patient and physician confusion and to enable a transparent system.   PBSA will provide further suggestions to the FDA on issues on which they have requested more public input.   One area we are particularly interested in is the development of and adverse event reporting system that is functional and universal.” 

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

International Foundation for Autoimmune Arthritis

Jeffrey Modell Foundation

Lupus and Allied Diseases Association

Lupus Foundation of America

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