It's final. The FDA is sticking with an alphabet soup approach to suffixes for nonproprietary, or proper, names for originator biologics, related biologics and biosimilars. But it's still scratching its head over the naming of interchangeables.
One of a spate of guidances the agency issued Thursday in the waning days of the Obama administration, the final guidance calls for biologic proper names to consist of a meaningless, four-letter, lowercase suffix attached to the core name with a hyphen. The FDA is encouraging the routine use of the suffixes in ordering, prescribing, dispensing, recordkeeping and pharmacovigilance practices.
The agency has already followed the naming scheme for all but one biosimilar it's approved. As the first out of the gate, Sandoz Inc.'s Zarxio was assigned a "placeholder" proper name with a suffix suggestive of its maker filgrastim-sndz. But subsequent biosimilars were given suffixes "devoid of meaning," to