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Specifically, the FDA issued a draft guidance that says biosimilars should have four-letter suffixes added to their names, but brand-name biologics that are already licensed – and do not currently have a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

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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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