FDA finalizes biologics naming guidance

In final guidance released Thursday on naming of biologic drugs, FDA reiterated that each biologic should receive a non-proprietary "core name" plus a unique four-letter suffix that is devoid of meaning. The naming convention, proposed in draft guidance released in August 2015, would apply to newly and previously approved originator biologics, related biological products, and biosimilars (see BioCentury Extra, Aug. 27, 2015).

Each biologic and biosimilar would receive a hyphenated "proper name" joining the core name with the suffix. The convention is designed to differentiate among non-interchangeable reference products and biosimilars...