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Specifically, the FDA issued a draft guidance that says biosimilars should have four-letter suffixes added to their names, but brand-name biologics that are already licensed – and do not currently have a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.
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