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ASBM Survey Reveals Key Safety Concern Associated with Biosimilar Naming; Urges Distinct Naming Requirement
Date:9/13/2012

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  • 85% of responding physicians want the authority to designate a biologic medicine as "Dispensed as Written", just as they have it for chemical products.
  • 86% of physicians want to be notified BEFORE a patient is switched to a biologic other than the one prescribed EVEN IF there are no known concerns associated with the product.

    • Dr. Dolinar, chairman of the Alliance, released the following statement about the conference and the survey results:

    "In the past 30 years, biologic medicines have revolutionized the treatment of patients with many diseases – but making copies of these highly complex medicines presents significant challenges for physicians and regulators.  This survey provides important information for effectively addressing these challenges.  Biologics are produced from living cells and copies will be only similar, not identical to the original.  This survey clearly indicates that physicians familiar with biologics know minor changes can make a big difference for sick patients. 

    "We have been very supportive of the FDA's efforts to create a pathway that ensures biosimilars are safe and effective for patients.  This survey demonstrates the potential safety consequences of giving different biologic products the same scientific name.  In order to avoid inappropriate substitution, all biologics should be required to have distinct names."

    Biologics are used to treat cancer, rheumatoid arthritis and other debilitating diseases. On February 9, 2012, the FDA announced the publication of draft guidance documents relating to the developments of biosimilars, which are similar to, but not exact copies of biologics. The guidance documents were a significant step in establishing a biosimilars pathway and as the FDA moves forward, ASBM will continue to work to ensure patient safety remains the priority.

    The survey was conducted by Industry Standard Resear
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    SOURCE The Alliance for Safe Biologic Medicines
    Copyright©2012 PR Newswire.
    All rights reserved

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