BPC believes that biosimilar product labeling should contain all needed data for physicians to make appropriate prescribing decisions for their patients. The label is a critical tool for physicians to both make prescribing decisions and manage potential adverse events, including side effects and drug-to-drug interactions. As such, it is of the utmost importance that any drug label be complete and accurate. BPC advocates for final labeling guidance that requires more transparent labeling, including: a statement of whether the biosimilar is interchangeable with the reference product and/or other biosimilars on the market; a summary of the full clinical data submitted in support of biosimilar approval or a hyperlink to that date, and the FDA’s summary basis of approval, including identifying where biosimilar properties, structure and function differ from the reference product. Additional perspective on this issue provided in our related material.
August 2, 2016 Physician Groups Applaud FDA on Biosimilar Labeling, Urge For Greater Transparency To Ensure Patient
October 27, 2015 Physician Groups Applaud FDA for Distinguishable Naming; But Argue Against ‘Random’ Suffix
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