2017-12-07 FDA Biosimilars Education

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FDA Biosimilars Educational Material

Posted: December 7, 2017

To date, the U.S. Food and Drug Administration (FDA) has approved seven biosimilars, and some are already on the market. As the biosimilars market continues to grow, there are still a lot of questions from both patients and physicians about these important new treatment options.

As more biosimilars are approved and made available to the public, the FDA has developed educational materials to help health care providers gain a better understanding of what these products are and how they can be prescribed to help patients. According to the agency, these resources are designed to:

• Provide the basic definitions for biological drugs, reference products, biosimilars, interchangeable products, and other terms.
• Facilitate understanding of the relationship between biosimilars and the biological products they were compared to, known as reference products.
• Describe the rigorous standards any biosimilar must meet prior to approval and explain how the FDA approval pathway works for these products.
• Provide easily accessible information about the data and information FDA reviews to determine biosimilarity and how to find more resources.

CSRO encourages rheumatologists to check out these resources to learn more about biosimilars and interchangeable products, the biosimilars already approved and those on the market, the FDA approval process, prescribing information, safety considerations, and other important information. The site also includes information about an important reference for biosimilars known as the “Purple Book.” This reference can help you easily identify which biological reference products currently have one or more FDA-approved biosimilar or interchangeable products.

• FDA Biosimilars Educational Materials
• FDA Biosimilars General Information Page
• FDA Purple Book