WASHINGTON, DC – February 23, 2018 – “Biosimilar medicines have the potential to increase patient access to life-saving treatments for millions of Americans. Patients for Biologics Safety & Access (PBSA) has always placed patient safety at the forefront of everything we do, and we have been actively engaged with the FDA to ensure a safe and effective biosimilar pathway to market. Americans need access to effective biologic and biosimilar medicines.”

 “We applaud the FDA for its prioritization of patient safety as part of its biosimilar education efforts. Our recent comments to the FDA on its biosimilar education materials were meant to enhance those materials and to ensure that prescribers and patients have a greater understanding of biosimilars in making treatment decisions. We are dismayed that our suggestions to the FDA’s education effort and our motives have been miscomprehended and apologize for any misinterpretation or confusion that may have followed.”

“As more biosimilars come to market, PBSA will continue to collaborate with the FDA and all stakeholders to ensure that the patient voice and perspective is front-and-center.”

 

American Autoimmune Related Diseases Association (AARDA) 

Hemophilia Federation of America (HFA) 

Immune Deficiency Foundation (IDF) 

International Foundation for Autoimmune & Autoinflammatory Arthritis

Jeffrey Modell Foundation

Lupus and Allied Diseases Association (LADA) 

United Spinal Association 

US Pain Foundation

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