FDA Releases Final Guidelines on Naming Biosimilars

The FDA recently released guidelines for naming both biologic medicines and biosimilar copies.

The guidelines state that biologic and biosimilar products must now contain a four-letter suffix following the active component (or what the FDA calls a “core name”). The four-letter suffix will not have any clinical meaning other than to differentiate competing biologic and biosimilar products. The guidelines note that the suffix for each product will be designated by the FDA. 

“Nonproprietary names that include distinguishing suffixes can serve as a key element to identify specific products in spontaneous adverse event reporting and to reinforce accurate product identification in billing and claims records used for active pharmacovigilance,” the FDA guidelines stated. “Other product-specific identifiers, such as proprietary names... may not be available or could change over time. A distinguishing suffix will also support the tracking of product-specific events over time, thereby enhancing the accurate attribution of product-specific adverse event reports.”

Those opposed to this guidance cited the lack of any clinical meaning to the suffix as a cause for concern. 

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During recent public comment in response to the proposed rule, Stephen Ostroff, MD, of the American Health Insurance Plans, stated that “biosimilars and biologics should be required to have the same name without any suffix. Further, we believe that the use of an FDA- designated suffix is unnecessary and will cause confusion among physicians, pharmacists, and patients.” 

The guidance also notes that current biologic and biosimilar product names will be changed to include the newly designated FDA four-letter suffix. For example, Zarxio (filgrastim; Sandoz), is currently listed as filgrastim-sndz (an abbreviation for Sandoz), but will be renamed filgrastim-bflm. In this case, “bflm” holds no clinical significance other than to differentiate the product from its biologic, Neupogen (filgrastim; Amgen), which will now be known as filgrastim-jcwp.

Other  product name changes include: Granix (filgrastim-vkzt; Sicor Biotech), Remicade (infliximab-hjmt; Janssen), Epogen (epoetin alfa-cgkn; Amgen), and Neulasta (pegfilgrastim-ljfd; Amgen). —David Costill