What’s in a name? FDA changes course for biosimilar names and upsets generic makers

In an unexpected move, the Food and Drug Administration has decided that biosimilar medicines should have distinct naming features from brand-name biologics in order to bolster patient safety, a step that has infuriated biosimilar manufacturers.

Specifically, the FDA issued a draft guidance that says biosimilars should have four-letter suffixes added to their names, but brand-name biologics that are already licensed – and do not currently have a suffix – will not need such a feature. In doing so, the agency is trying to settle a long-running debate over the best approach for naming biosimilars, which has vexed regulators and divided drug makers over patient safety and the potential for big profits.