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FDA launches educational campaign for biosimilars Posted 27/10/2017

In light of the increasing number of biosimilars becoming available in the US, the US Food and Drug Administration (FDA) announced on 23 October 2017 the launch of its education campaign for biosimilars.

The agency says that ‘biosimilars can potentially reduce costs for consumers by creating price competition for products that previously faced few market competitors’. Therefore, it wants ‘to make sure providers are properly informed about biosimilars’ and that they know that ‘biosimilars are safe, effective treatment options’.

FDA’s Center for Drug Evaluation and Research (CDER) has approved seven biosimilars to date [1]. As more biosimilars are approved by FDA, the agency wants ‘healthcare providers to understand what these drugs are, and how they can help patients’, which is the reason for the launch of the educational materials.

The educational materials include fact sheets and graphics for healthcare professionals, as well as materials for organizations to use in disseminating this information to their interested members. These resources: 

  • Provide the basic definitions of terms like: biological product, reference product, biosimilar, interchangeable; and other terms to facilitate understanding of 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; and,
  • Provide easily accessible information about the data and information FDA reviews to determine biosimilarity and how to find more resources.

The materials can be found on FDA’s website, where attention is also directed to the ‘Purple Book’. This book, says the agency, is ‘an important reference for biosimilars’ that ‘can help prescribers and patients learn which biological reference products currently have one or more approved biosimilar or interchangeable product approved by FDA’.

The Purple Book is a set of lists of licensed biological products and biosimilars that is meant to be the biological equivalent of the ‘Orange Book’, which lists pharmaceuticals and their generic drug equivalents [2].

This is not the end of FDA’s educational efforts. The next step the agency is planning is to carry out ‘additional research with healthcare professionals to learn more about the types of information prescribers need to properly communicate with their patients about biosimilars’.

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1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Oct 27]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
2. GaBI Online - Generics and Biosimilars Initiative. FDA updates purple book for biologicals and biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Oct 27]. Available from: www.gabionline.net/Biosimilars/General/FDA-updates-purple-book-for-biologicals-and-biosimilars

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Source: US FDA

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