PBSA advocates that patients have access to safe and effective biologic and biosimilar medicines. Biologics are complex therapies that treat a multitude of difficult, life-threatening diseases such as rheumatoid arthritis, Crohn’s disease, cancer, diabetes, heart attacks, multiple sclerosis, and many rare diseases, among others. Biologics have revolutionized health care and, despite being relatively new, are already being used by millions of patients in the United States. 

Biologic medicines are made from living organisms and are far more complex than traditional chemical drugs. Biosimilars are medicines that are highly similar, but not identical to biological medicines. Because of the uniqueness and complexity of biologics, biosimilars are not generic copies of biologic medicines. The FDA has the authority to approve biosimilars and there are many key decisions that are unknown that can impact patient safety.

PBSA other patient advocates are working to ensure that biosimilars are introduced to patients in the U.S. in the safest manner possible.  As the US Food and Drug Administration considers approving biosimilar treatments, there are many patient safety questions that need to be answered.   The potential for cost savings should never trump patient safety.

On this page you will find resources that we’ve accumulated from patient groups engaged on this critical issue, as well as educational information developed by PBSA.