Resources

These resources provide answers around what biosimilars are, why they are important, how they can improve patient access, and how they can save the United States billions of dollars.

If there is something that you want to know and can’t find in the below links, we encourage you to send us an email and ask your question. We will try to get back to you as soon as possible and are always happy to talk about biosimilars.

Council Resources

Statements of Support

CAGW agrees with the comments made by a representative from the Biosimilars Council before the Arthritis Advisory Committee on July 12, 2016 that stated:

“FDA has used comparability, or extrapolation of information, for nearly 20 years. In such cases, clinical data are typically provided to confirm safety and efficacy of one indication and, taking into account the totality of information gained from the comparability exercise. Based on the acceptable outcome of the comparability and clinical evaluations, the data may then be extrapolated to the other indications.”

Council Statements

General Resources

Legislation