In an Attempt at Clarity, FDA Makes the Biosimilar Naming Convention Even More Confusing

The U.S. Food and Drug Administration (FDA) and some biosimilar and generic drug advocates were concerned that the naming for biosimilars the branded drug’s name and a unique, four-letter suffix made the drugs sound inferior to consumers than their branded counterparts. So in January 2017, the agency decided to retroactively add a suffix to all previously approved biologic drugs. Now they’ve changed their mind. And it seems likely consumers won’t notice one way or the other. A biologic drug, or biologics, is produced from living organisms. Most of the current top-selling drugs in the world, like AbbVie’s Humira, are biologics. But some classic older drugs, like insulin, are also biologics. A biosimilar is, essentially, a generic version of a biologic. However, unlike a generic of a small-molecule drug, which is an exact copycat, biosimilars are—as the word implies—similar to the brand drug, but not an exact copycat. As such, they are required to go through an approval process similar to that of the original branded medicines. Their clinical activity is identical or extremely close, but there are concerns that the labeling implies the biosimilars aren’t as effective or as safe as the originator drugs.