The Food & Drug Administration (FDA) released draft guidance and a related proposed rule on the naming of biologic drugs and biosimilars. The draft guidance proposes that reference products and biosimilars have nonproprietary names (also called proper names in the guidance) that share a core drug substance name and, in order to better identify each product, an FDA-designated suffix that is unique for each product. This suffix would be composed of four lowercase letters that won't carry any meaning.

    According to the FDA, the draft guidance addresses two key issues:

    • To help prevent inadvertent substitution (which could lead to medication errors) of biological products that aren't determined to be interchangeable by the FDA.
    • To support safety monitoring of all biological products after they are on the market, by making it easier to accurately track usage of biological products in all settings of care, such as outpatient, hospital and pharmacy settings.
    The proposed rule designates official names and proper names for six previously approved products. The FDA posted a blog posting about the naming policies. Comments on the draft guidance are due October 27, 2015.

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