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Specifically, the FDA issued a draft guidance that says biosimilars should have four-letter suffixes added to their names, but brand-name biologics that are already licensed – and do not currently have a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


At issue is the extent to which biosimilars should be distinguished in the marketplace. A biosimilar, you may recall, is a nearly identical variant of a brand-name biologic medicine that has no clinically meaningful differences in patients, but comes at a lower cost. A 2017 report by the Rand Corp.  estimated biosimilars could save the U.S. healthcare system about $54 billion over the ensuing decade.

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