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FDA Develops Educational Materials on Biosimilars

Dec 14, 2017

As of October 2017, the FDA has approved seven biosimilars. While these medications weren’t for diabetes, that may be coming. People with diabetes are starting to hear about biosimilars, which offer more treatment options. 

To help healthcare providers understand what these products are and how they can be prescribed, the agency has developed a set of educational materials that: 

  • Provide basic definitions of terms like: biological drugs, reference products, biosimilar, interchangeable; and other terms to facilitate understanding the relationship between biosimilars and their reference products
  • Describe the rigorous standards any biosimilar must meet prior to approval and explain how the FDA approval pathway works for these products
  • Contain details about the data and information FDA reviews to determine biosimilarity, and how to find more information
  • Provide information about prescribing biosimilar and interchangeable products

Take a look and stay tuned for an article on biosimilars in an upcoming issue of AADE in Practice.

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