The Alliance for Patient Access / IfPA’s Patient Access Policy Blog / IfPA Policy Brief Calls for Transparent Biosimilar Labeling

IfPA Policy Brief Calls for Transparent Biosimilar Labeling

by Amanda Conschafter, blog editor

In the Institute for Patient Access’ new policy brief, “Informed Prescribing,” authors David Charles, MD, and Mary Ann Chapman, PhD, explain why biosimilar medications should come with transparent, accurate prescribing information. Also known as the “package insert” or “product label,” prescribing information includes basic details and testing data that physicians need when prescribing medications. Generic versions of traditional drugs often include only the data for their brand-name reference product. But the brief argues that applying this practice to biosimilars and biologics won’t properly inform physicians or protect patients.

The brief outlines three primary reasons that physicians need clear prescribing information about biosimilars – and not just about their biological reference product:

  1. Testing data on the biosimilar offers the prescribing physician valuable information about dosing, effectiveness and safety – including adverse events in response to the medication.
  1. Each patient group can respond differently to different biological medicines. But including study information from the biologic may suggest that the biosimilar has been tested in patient groups when it actually has not.
  1. Prescribing information should reflect biosimilars’ distinction from biologics, as do the FDA’s interim biosimilar naming approach and many state bills on communication of biosimilar substitutions.

Informed Prescribing” defines a transparent prescribing information package as one that addresses:

  • Whether the medication is a biosimilar
  • Data from studies conducted with the biosimilar
  • Whether each study included was conducted with the biosimilar or original biologic
  • The patient groups and disease states for which the biosimilar was tested.

With the FDA’s first biosimilar approval, for Zarxio, the biosimilar included labeling identical to that of the reference biologic. The decision stirred concerns about creating a precedent in which physicians lack full and specific knowledge about the biosimilar they’re prescribing.

Read “Informed Prescribing” to learn more.

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The Alliance for Patient Access is a national network of physicians dedicated to ensuring patient access to approved therapies and appropriate clinical care.
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