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Authors

  1. Aschenbrenner, Diane S. MS, RN

Abstract

* The Food and Drug Administration has created several online educational resources for health care professionals on biosimilar and interchangeable products.

 

* These free resources can be used either for personal development or for patient education.

 

 

Article Content

In 2009, Congress created a smoother pathway to Food and Drug Administration (FDA) approval for new, generic products that were considered biosimilar to or interchangeable with products already approved by the FDA. The FDA defines a biosimilar product as "a biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product." For a biosimilar product to be considered an interchangeable product, it must demonstrate that it is expected to produce the same clinical results as the reference product. An interchangeable product may be substituted for the reference product without notification to the provider, while a biosimilar drug that is not considered to be interchangeable requires a specific prescription from the provider. Biosimilar and interchangeable products meet the FDA's approval standards and have the same safety and effectiveness as the original reference product.

 

Health care professionals may have questions about biosimilar products and interchangeable products and the implications these medications may have for their practice. For this reason, the FDA has designed educational materials for nurses, NPs, and other health care professionals on these products and is making them available on a Biosimilars web page (see http://links.lww.com/AJN/A99). Links on the web page provide information and printable fact sheets on biosimilar and interchangeable products; biosimilar development, review, and approval; prescribing biosimilar and interchangeable products; industry information and guidance; online courses, webinars, and presentations; and patient and prescriber outreach materials. An online continuing education (CE) course, FDA Overview of Biosimilar Products, provides CE credits, which are available until February 17, 2019. The patient and prescriber outreach links include a printable graphic that could be posted in a clinic or office and used for patient education; brief animated GIFs (graphics interchange format) about biosimilars that can be shared; and social media posts for external stakeholders to use and share on Twitter, Facebook, and LinkedIn.

 

Nurses and NPs should take advantage of these free educational materials to increase their knowledge and to provide appropriate patient education.